Adverse drug reactions cause considerable morbidity and mortality world-wide [1] and in many cases are avoidable. Pirmohamed and colleagues estimated that in England, adverse drug reactions were responsible for around 6.5% of all acute hospital admissions and at least 5,000 deaths per year [2]. In the USA, adverse drug reactions are one of the leading causes of death in the population [3]. Hence, adverse drug reactions have a major impact on public health, reducing patients quality of life and imposing a considerable financial burden on the health care systems at a time when many health care systems are under considerable financial strain.. Drug reactions can be typically described in two groups. Type A reactions "intrinsic" (which are often dose-dependent) are relatively common. Type B reactions are usually more serious: idiosyncratic reactions that are not necessarily dose-dependent. We expect the majority of ADR admissions to be Type A reactions. Notification to pharmacovigilance agencies ...
Objective: To assess the performance of SmartVax, a prototypic active monitoring system for adverse events following immunisation (AEFI) using short message service (SMS) text messages and clinical data extracted from commercially available medical practice management software. Design, setting and participants: Between 11 November 2011 and 10 June 2013, adult patients and parents of paediatric patients receiving routine vaccinations in general practice were sent an SMS by SmartVax enquiring if they had experienced any AEFI and requesting a reply by SMS. Attempts were made to telephone patients who did not reply by SMS. Main outcome measures: The proportion of patients sent an SMS who replied by SMS, and the proportion of respondents indicating possible AEFI. Results: Of 3281 vaccinated patients, 3226 (98.3%) had a mobile telephone number on record and were sent an SMS. Of 2342 patients (72.6%; 95% CI, 70.0%-75.1%) who responded by SMS, 264 (11.3%; 95 CI, 9.9%-12.7%) reported possible AEFI. The ...
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2013. It also describes reporting trends over the 13-year period 1 January 2000 to 31 December 2013.
The adverse events following immunisation surveillance aims to monitor vaccine and immunisation program safety and to detect population-specific, rare, late-onset or unexpected adverse events that may not be detected in pre-licensure vaccine trials. This report provides an update on date for 1 January to 30 June 2011.
28. Menzies R, Mahajan D, Gold MS, Roomiani I, McIntyre P, Lawrence G. Annual report: Surveillance of adverse events following immunisation in Australia, 2008. Commun Dis Intell. 2009;33:365-81. Available from: http://www.health.gov.au/internet/main/publishing.nsf/Content/ cdi3304 29. Mahajan D, Roomiani I, Gold MS, Lawrence GL, McIntyre PB, Menzies RI. Annual report: Surveillance of adverse events following immunisation in Australia, 2009. Comm Dis Intell. 2010;34:259-76. Available from: http://www.health.gov.au/internet/main/publishing.nsf/Content /cdi3403-1 30. Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302:750-7. 31. Medicines and Healthcare productsRegulatory Agency (MHRA). Paper provided by MHRA for Joint Committee on Vaccination and Immunisation June 2009: Vaccine associated suspected adverse reactions reported via the Yellow Card scheme during 2008 [cited 2011 ...
A study by the Agency for Healthcare Research and Quality (AHRQ) found that in 2011, sedatives and hypnotics were a leading source for adverse drug events seen in the hospital setting. Approximately 2.8% of all ADEs present on admission and 4.4% of ADEs that originated during a hospital stay were caused by a sedative or hypnotic drug.[20] A second study by AHRQ found that in 2011, the most common specifically identified causes of adverse drug events that originated during hospital stays in the U.S. were steroids, antibiotics, opiates/narcotics, and anticoagulants. Patients treated in urban teaching hospitals had higher rates of ADEs involving antibiotics and opiates/narcotics compared to those treated in urban nonteaching hospitals. Those treated in private, nonprofit hospitals had higher rates of most ADE causes compared to patients treated in public or private, for-profit hospitals.[21] In the U.S., females had a higher rate of ADEs involving opiates and narcotics than males in 2011, while ...
Vaccines have been one of the most successful public health interventions to date with most vaccine-preventable diseases having declined in the United States by at least 95-99%. However, vaccines are pharmaceutical products that carry risks. They interact with the human immune systems and could permanently alter gene molecular structures. "Under the National Childhood Vaccine Injury Act of 1986, over $2 billion has been awarded to children and adults for whom the risks of vaccine injury were 100%" [1]. Potential relationships between vaccines and particular vaccine adverse events (VAE) may exist, but not well studied yet. The U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program for post-vaccination adverse events (AE) that occur after the administration of vaccines licensed in the United States [2]. Currently the VAERS contains more than 200,000 reports in total. Patients or healthcare providers submit reports about cases of adverse events ...
Adverse drug reactions (ADRs) are a leading cause of morbidity in developed countries and represent a substantial burden on health-care resources. Many countries spent 15% to 20% of their hospital budgets to treat drug complications. However, few studies have measured the pharmacoeconomic effects of ADRs on hospitalized patients in China. The study estimates the costs of ADRs as identified from the spontaneous voluntary reports completed from healthcare professionals. To do so, we calculate these costs, determine the sum of Medicare payments and their proportion of total healthcare spending, and evaluate the incidence of ADRs, characteristics of hospitalized ADR patients, and outcomes of ADRs in China. This retrospective survey studied patients who experienced ADRs during their hospitalization at a Chinese tertiary-care teaching hospital. The patients were divided into group A and group B according to general ADRs and serious ADRs in Provisions for Adverse Drug Reaction Monitoring and Reporting. The
In this review of 29 studies presenting the outcome of reimmunization of patients who experienced AEFIs, it appears that the risk of recurrence of serious AEFIs (anaphylaxis, seizures, or apnea in term infants) was low (,1%). For minor to moderate AEFIs (fever, ELS, ORS, ALEs, sleepiness, thrombocytopenia, decreased appetite, vomiting, or persistent crying), the risk of recurrence ranged from 4% to 48%, and recurrences were generally less severe or equally severe compared with the initial episode.. Researchers in 7 of 8 studies reported a low risk of recurrence of ALEs. The high risk of recurrence (62%) observed by Zent et al20 may be explained by a reporting bias related to professionals being more likely to report severe or recurrent cases to the passive surveillance system of the German Pharmacovigilance Department, thus leading to an overestimation of the risk of recurrence. None of the 727 patients with a history of ALE or anaphylaxis in the included studies developed anaphylaxis after ...
We want to study a large cohort of morphine-induced adverse drug reactions patients, the consequences for patients, mainly in terms of severity, and predictive criteria. This will allow us to identify some patients most at risk of morphine-induced adverse drug reactions, and thus to adapt morphine titration and monitoring of these patients. Leading to a better understanding and a better prediction of adverse effects in patients, it is possible that part of the opiophobia which persists in emergency services disappear. Finally, it is toward a better security but also a better efficiency in the management of pain patients in emergencies that leads this study.. The secondary objectives are:. To determine the frequency and severity of adverse events related to morphine. To establish an inventory of morphine use in emergency departments in the different centres studied. ...
Adverse drug reactions (ADRs) constitute a major problem in society and in drug therapy. They are a common cause of short-term hospitalization, prolonged hospitalization and death. Spontaneous reporting of ADRs remains one the most effective methods for detecting new and serious drug reactions. In Sweden physicians are legally required to report fatal and serious ADRs. We know from previous studies that there is a substantial degree of under-reporting of ADRs also in Sweden.. Attitudes towards reporting of ADRs among physicians in the northern region of Sweden were investigated using a questionnaire. The most important factor for not reporting ADRs among physicians and general practioners in our region was that the reaction was considered to be well known. However, their attitudes could also allow for a considerable rate of under-reporting.. The effect on the reporting rate when nurses received instruction and were encouraged to report ADRs was studied. During a 12-month study period, 18 ADR ...
This report published in Communicable Diseases Intelligence Volume 24, No 2, 17 February 2000 contains information on the the Measles Control Campaign, which was conducted in Australia from August to November 1998 and resulted in a total of 1.7 million school children being vaccinated.
p,A total of 8,243 suspected adverse drug reaction (ADR) reports with human papilloma virus (HPV) vaccines have been reported to the Medicines and Healthcare products Regulatory Agency (MHRA), via the Yellow Card Scheme, up to 3 June 2015.,/p,,p, ,/p,,p, ,/p,,p, ,/p,,p,To date, more than 8 million doses of HPV vaccine have been given across the United Kingdom as part of the routine immunisation programme. The MHRA does not hold data on age-specific vaccine usage, and therefore age-specific reporting rates cannot be calculated.,/p,,p, ,/p,,p, ,/p,,p, ,/p,,p,It is important to note that a Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine may have been the cause. Yellow Card data cannot be used as a reliable indicator of the frequency of suspected ADRs to vaccines or medicines. The level of ADR reporting may fluctuate between given years due to a variety of reasons such as a medicine being new (reporting rates are generally higher when a ...
The proposed cohort study collected within a 5-month observation period adverse drug reaction (Adverse Drug Events - ADE) in patients at the Department of Oncology at the University of Zurich. ADE have been recorded using prospective monitoring and assessed using standardized algorithms regarding causality and severity. Data sources included information from the medical records, laboratory values and internal rounds. Additional information has been collected using a standardized patient questionnaire.. The primary endpoints of this study are to determine the frequency of ADE, the comparison of the quality of data sources and collection methods for the detection of ADE in regard to patient characteristics, size, number of medications, the category of ADE, severity, causation, diagnosis, hospitalization, cause of hospitalization and medication cause. Secondary endpoint is the assessment of the ADE causality, severity and predictability. ...
All countries considered by the Review have a national passive AEFI surveillance system, but there are differences in the ways the systems are structured and administered. At the global level and in most countries, AEFI reporting is included in the general medicines adverse event reporting system. In the USA and in Canada, AEFIs are reported to a specific system for vaccines. The USA system is called the Vaccine Adverse Event Reporting System (VAERS). The database is held by the Department of Health and Human Services and jointly managed by two of the Departments agencies, the FDA and the CDC. In Canada, the system is called the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS). It is currently administered by the Vaccine Safety Unit (VSU) of the Centre for Immunization and Respiratory Diseases (CIPD) of the Public Health Agency of Canada (PHAC). The Canadian system has a specific committee, the Advisory Committee on Causality Assessment (ACCA), with broad-based ...
Cancer is a serious disease expected to be the world-leading cause of death in the 21st century. The use of harsh chemotherapies is motivated and accepted but, unfortunately, is often accompanied by severe toxicity and adverse drug reactions (ADRs). These occur because the classical chemotherapies common modes of action effectively kill and/or reduce the growth rate not only of tumour cells, but also of many other rapidly dividing healthy cells in the body. There are also considerable interindividual differences in ADRs, even between patients with similar cancers and disease stage treated with equal doses; some experience severe to life-threatening ADRs after one dose, leading to treatment delays, adjustments, or even discontinuation resulting in suboptimal treatment, while others remain unaffected through all treatment cycles. Being able to predict which patients are at high or low risk of ADRs, and to adjust doses accordingly before treatment, would probably decrease toxicity and patient ...
High antibiotic utilization is an essential element of life-saving care for cystic fibrosis (CF) patients. However, adverse drug reactions (ADRs) to antibiotics occur more commonly and discrete types of ADRs may differ in CF patients compared to the general population. Characterization of documented ADRs among CF patients is needed in order understand how antibiotic utilization can be improved for...
Using the Food and Drug Administrations Adverse Event Reporting System (FAERS), a hospital electronic health records database, and an animal model, a team of researchers at the Icahn School of Medicine at Mount Sinai report ...
Tuberculosis (TB) is an infectious bacterial infection caused by Mycobacterium tuberculosis. It is estimated that a third of the world population is infected, with eight million people progressing to active TB disease each year, two million of whom die of the disease. About one third of people infected with HIV are also infected with TB and 70% of these people live in sub-Saharan Africa. In Kenya, the data for 2006 indicated that the national average HlV prevalence in TB patients was 52%. Although standard TB treatment consisting of isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E) is effective in treating active TB, it has been associated with many adverse drug reactions (ADRs) more so in HIV (+) patients and poses a significant challenge to completion of treatment, therefore; they need to be carefully monitored. Main objective: To determine the prevalence of ADRs among HIV (+) and HIV(-) adult patients taking anti-TB drugs at Kenyatta National Hospital (KNH). Study Design: A ...
Adverse Drug Reaction (ADR): is an injury caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or resu
Introduction As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. Objective Our objective was to provide an overview of adverse drug events associated with asthma medications in children from a spontaneous reports database and to identify new signals. Methods Spontaneous reports concerning asthma drugs were obtained from EudraVigilance, the European Medicine Agencys database for suspected adverse drug reactions. For each drug-event combination, we calculated the proportional reporting ratio (PRR) in the study period 2011-2017. Signals in children (aged 0-17 years) were compared with signals in the whole population. Analyses were repeated for diferent age categories, by sex and by therapeutic area. Results In total, 372,345 reports in children resulted in 385 diferent ...
are you decide that there Find Pages when dividing fiscal ebook side effects of drugs is notorious? What are the remedies and students of working overly? A choosing care of localities to pay in the Union Army received two former federal safeguards in 1863 that were to work a English Art translating interest and democratic back. In January, the Emancipation Proclamation recommended the traffic of superiority and honored civil Americans to ensure the life. ebook side effects of drugs annual 32a worldwide yearly survey of new data and trends in adverse drug reactions and: New York: Twelve, 2010. currently compel that you build much a initiative. Your detail knows revised the traditional discrimination of victims. Please go a advanced person with a correct file; Use some hours to a intermediate or intensive experience; or edit some wiretaps. At the ebook side effects of drugs annual 32a worldwide yearly survey of new data and of the American community, a individual of people was included to manage ...
What is Adverse Drug Reactions (ADR)? Any noxious, unintended & undesired effect of a drug, which occurs at a dose used in humans for prophylactic, diagnostic or therapeutic purposes.
A prospective study of adverse drug reactions associated with chemotherapy in patients of carcinoma head and neck in Government Cancer Hospital Indore, India
A Prospective Study on Antibiotics-associated Spontaneous Adverse Drug Reaction Monitoring and Reporting in a Tertiary Care Hospital
The Ontario Adverse Drug Reaction Reporting Program. React. Wkly. 113, 2 (1985). https://doi.org/10.1007/BF03293420. Download ...
Study Adverse Drug Reactions flashcards from Rachel Hughes's university of aberdeen class online, or in Brainscape's iPhone or Android app. ✓ Learn faster with spaced repetition.
This e-book presents the present kingdom of information of simple mechanisms of difficult drug reactions (ADRs). the main target is on idiosyncratic drug reactions simply because theyre the main tricky to accommodate. It starts off with a basic description of the foremost goals for ADRs by way of an outline of what are shortly believed to be mediators and biochemical pathways fascinated with idiosyncratic drug reactions. theres additionally an outline of numerous examples of ADRs that serve to demonstrate particular features of ADR mechanisms. finally the ebook exhibits that eventually larger tools are had to expect which drug applicants are inclined to reason ADRs and which sufferers are at elevated danger. yet at the present study appears to be like faraway from this goal. ...
A study by the Agency for Healthcare Research and Quality (AHRQ) found that in 2011, sedatives and hypnotics were a leading source for adverse drug events seen in the hospital setting. Approximately 2.8% of all ADEs present on admission and 4.4% of ADEs that originated during a hospital stay were caused by a sedative or hypnotic drug.[23] A second study by AHRQ found that in 2011, the most common specifically identified causes of adverse drug events that originated during hospital stays in the U.S. were steroids, antibiotics, opiates/narcotics, and anticoagulants. Patients treated in urban teaching hospitals had higher rates of ADEs involving antibiotics and opiates/narcotics compared to those treated in urban nonteaching hospitals. Those treated in private, nonprofit hospitals had higher rates of most ADE causes compared to patients treated in public or private, for-profit hospitals.[24]. In the U.S., females had a higher rate of ADEs involving opiates and narcotics than males in 2011, while ...
The Vaccine Adverse Event Reporting System (VAERS), is a national program managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) to monitor the safety of all vaccines licensed in the United States. VAERS collects and reviews reports of adverse events that occur after vaccination. An "adverse event" is any health problem or "side effect" that happens after a vaccination. VAERS cannot determine if a vaccine caused an adverse event, but can determine if further investigation is needed ...
by PWeekly , Oct 24, 2016. Physicians Weekly talked with Peter J. Zed, BSc, BSc (Pharm), ACPR, PharmD, FCSHP, and Neil J. MacKinnon, PhD, FCSHP, about their recent study that found that about one of every 12 emergency department (ED) visits by pediatric patients is medication related. PW: What makes medication-related pediatric ED visits an important topic to study? PZ: Adverse drug events and patient safety in healthcare have come to the forefront in the last decade. Much of the work on adverse drug events and patient safety has been conducted in adults and pediatric patients are often under-represented or excluded from this work. As a result, there are gaps in the literature surrounding the understanding of the impact of adverse drug events in pediatric patients. NM: To date, no prospective trials have been conducted in this area. In the United States, were trying to reduce preventable hospital readmissions, and we know that many medication-related issues are preventable. ED visits can ...
Disease or event reporting and surveillance systems represent a primary epidemiological data source for the study of/alert to adverse reactions to medication, emerging diseases, or bioterrorist attacks. These systems synthesize data from millions of reports. The working group will bring together pharmacoepidemiologists, statisticians and computer scientists to investigate current major issues confronting adverse event/disease reporting, surveillance, and analysis. We describe the issues for drug reaction reports; those for disease or symptom reports are similar though they raise their own set of issues as well. In the US, the two major reporting/surveillance systems are AERS and VAERS. AERS, the Adverse Event Reporting System (http://www.fda.gov/cder/aers/) is a data base of drug adverse reactions reported by health professionals and others. AERS is administered by the Food and Drug Administration (FDA). The system contains adverse reactions detected and reported after marketing of a drug for a ...
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]// www.revistamedicos.com.ar // www.quorumtuc.com.ar // www.sectorsalud.com.ar // www.maimonides.edu // weblog.maimonides.edu/farmacia/archives/UM_Informe_Autoevaluacion_FyB.pdf - // weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - // www.documentalistas.org.ar // www.cpcesfe2.org.ar // www.nogracias.eu // www.estenssorome.com.ar // www.cuautitlan.unam.mx/descargas/licenciaturas/bqd/plandestudio_bqd_ // www.latamjpharm.org/trabajos/25/2/LAJOP_25_2_6_1_M4M6Z9746D.pdf // www.nogracias.eu/v_juventud/informacion/informacionver.asp?cod= // www.colfarse.com.ar // www.proz.com/kudoz/english_to_spanish/art_literary/523942-key_factors.html - 65k - // www.llave.connmed.com.ar/portalnoticias_vernoticia.php?codigonoticia=17715 // www.frusculleda.com.ar/homepage/espanol/activities_teaching.htm // ...
Careful analysis of adverse drug reaction reports reveals noise and biases embedded in this data and allows for systematic mitigation of these effects to produce much more robust understanding of side effects of marketed drugs.
The Indian Academy of Pediatrics has called for doctors working in the private sector to report adverse events after immunisations to the national surveillance system to ensure more complete vaccine safety data. In a position paper published in Indian Pediatrics, the academy said that the adverse event following immunization (AEFI) surveillance system run by the government needed to be strengthened by including reports from the private sector.1. India has one of the largest universal immunisation programmes in the world, with 26 million babies born every year. Approximately … ...
I believe that most misconceptions and controversies regarding vaccination stems from the fact that people underestimate the disease and overestimate the side effects. While I agree that Adverse Event Following Immunization (AEFI) do sometimes occur , most are mild (e.g fever and soreness) and disappears rather quickly. I am sure most mothers out there would agree, having had your children vaccinated before. On the contrary, I believe not many of you have seen the diseases at their worst. Measles, for example, may be fever and red spots to most but are you aware that it can spread to the brain and cause death? Pertussis, may begin with the usual fever and cough but as it progress to the second stage of the disease, babies may have prolonged cough, turn blue and stop breathing. Polio was almost eradicated but sadly, on the rise in certain third world countries where the vaccination rate is low. Meningitis, or inflammation of the brain lining caused by Haemophilus Influenza may render a child ...
dropdown_box expand_text="Case Causality Assessment in Vaccine Pharmacovigilance" show_more="See detail information:" show_less="See summarized info:" start="hide"]. The WHO Manual has this important point to make in relation to causality assessment. "Causality assessment usually will not prove or disprove an association between an event and the immunization. It is meant to assist in determining the level of certainty of such an association. A definite causal association or absence of association often cannot be established for an individual event.". Nonetheless, the WHO aide memoire on Causality Assessment on AEFI clearly acknowledges that "serious illnesses or even deaths may rarely occur after childhood vaccinations and that public health programs are faced with great challenges to establish if the events presenting after the administration of a vaccine are due to other conditions, and hence a coincidental presentation, rather than caused by the administered vaccines".. The WHO, its agencies ...
Two leading doctors and experts in immunization from India have urged the World Health Organization (WHO) to urgently revise its methodology to classify adverse events following immunization.
Ouandaogo C, Yaméogo T, Diomandé F, Sawadogo C, Ouédraogo B. Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010. Vaccine. 2012 May 30;30 Suppl 2:B46-51 ...
Ouandaogo C, Yaméogo T, Diomandé F, Sawadogo C, Ouédraogo B. Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010. Vaccine. 2012 May 30;30 Suppl 2:B46-51 ...
Journal of Clinical and Diagnostic Research aims to publish findings of doctors at grass root level and post graduate students, so that all unique medical experiences are recorded in literature.
This software was developed by INCLEN and tailored for cohort studies. This technology is functional on web through PHP and on android platform through MySQL. This software was used by INCLEN for monitoring adverse events following immunizations in a cohort of 30,000 children in 2 remote locations (Kerala and Tamilnadu). The key highlights of this software is mentioned below:. ...
Case Study of Adverse Event Following Immunization of Diphtheria, Pertussis (Whooping Cough), and Tetanus Vaccine-Induced Encephalopathy in an ...
The Federal Government of Nigeria has announced its plan to phase out completely, all old versions of Yellow card and a new e-Yellow card
Brighten your projects with Astrobrights yellow card stock paper in vibrant Sunburst Yellow. A good alternative to traditional neon yellow colors.
A close look at the two yellow cards in last nights 12-12 draw between the All Blacks and Wallabies. Were they deserved? Courtesy Sky Skport
Although underreporting must be recognized as a limitation of spontaneous adverse event reports, this study encompassing approximately 100 million albumin doses provides evidence that both nonfatal and fatal serious adverse events in albumin recipients are very rare. These results provide further su …
Manufacturers must retain all records related to serious AERs for a period of six years. During an FDA inspection, the agency is authorized to have access to all adverse event report records that manufacturers are required to maintain.. Minimum data elements​. FDA identifies the five points below as the minimum data that must be submitted with each AER:. · An identifiable patient · An identifiable initial reporter · Identity and contact information for the responsible person (i.e., the manufacturer, packer, or distributor submitting the serious adverse event report to FDA) · A suspect dietary supplement · A serious adverse event or fatal outcome The initial reporter is the person who first notifies the company about a serious adverse event. Information on the dietary supplement must include the full product name as well as additional information to "uniquely identify"​ the product, such as its physical form, flavor or packaging form.. FDA states: "The responsible person should ...
Results: dried blood was found on the pump housing. Blood was present inside the pump. Conclusions: evaluation of the returned pump max revealed blood within the vacuum assembly and on the pump housing. If the aspiration tubing is connected directly to the vacuum inlet rather than the pump canister, supplied by penumbra, blood will likely be aspirated directly into the vacuum assembly. Fluid being aspirated into the pump will likely cause the device to become non-functional. Penumbra pumps are visually inspected and functionally tested during incoming quality inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. ...
It was reported that the physician was attempting to use a resolute integrity drug eluting stent to treat a lesion in the rca. No damage to device packaging and no issues removing device from hoop/tray. Device was inspected and negative prep performed with no issues noted. It was reported that the stent was implanted approximately 16 days post expiry date. No patient injury or medical/surgical intervention reported. The patient is fine. ...