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U.S. Department of Health and Human Services

MedSun: Newsletter #35, April 2009

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Newsletter #35, April 2009

Articles

Class I Recall: Welch Allyn AED 10 and and MRL JumpStart Defibrillators

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FDA MedWatch Safety Alert

FDA and Welch Allen notified healthcare professionals and consumers of a nationwide Class I recall of 14,054 AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002 and January 25, 2007. These devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference. If such issues arise, it may prevent defibrillation of a patient in cardiac arrest and could lead to death.

Additional Information:

Class I Recall: Welch Allyn AED 10 and and MRL JumpStart Defibrillators. FDA MedWatch Safety Alert. March 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127781.htm

Class I Recall: Welch Allyn AED 10 and and MRL JumpStart Defibrillators. FDA Recall. December 15, 2008.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm122797.htm

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Class I Recall: Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter

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FDA MedWatch Safety Alert

Baxter has recalled several model numbers of the Colleague Single and Triple Channel Volumetric Infusion Pumps. The recall is due to the possible occurrence of software and battery usage failures that may result in a delay or in interruption of infusion that could cause serious injury or death. Baxter sent it’s customers a letter that included recommendations and instructions to hospitals on using the infusion pumps.

Additional Information:

Class I Recall: Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter. FDA Recall.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm117583.htm

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FDA Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings.

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FDA is warning healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. FDA recommends that healthcare professionals referring patients to have an MRI identify those patients who are wearing a patch before they have the MRI.

Additional Information:

Transdermal Drug Patches with Metallic Backings. FDA MedWatch Safety Alert. March 10, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm111493.htm

Risk of Burns During MRI Scans from Transdermal Drug Patches with Metallic Backings. FDA Public Health Advisory. March 10, 2009.
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm111313.htm

FDA Warns About Risk of Wearing Medicated Patches During MRIs. FDA Press Release. March 5, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149537.htm

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Reporting Medical Errors to Improve Patient Safety: A Survey of Physicians in Teaching Hospitals

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By: Kaldjian, LC; Jones, EW; et al
Copyright © 2009 American Medical Association. All Rights Reserved.

In a recent survey of doctors, 92% said they would likely report a hypothetical error resulting in major harm to a patient. But only 4% of respondents had reported an actual major error. To improve patient safety, it is necessary to understand the frequency, seriousness, and causes of medical errors.

Additional Information:

Reporting Medical Errors to Improve Patient Safety: A Survey of Physicians in Teaching Hospitals. Kaldjian, LC; Jones, EW; et al. Archives of Internal Medicine: American Medical Association. 2008;168(1):40-46.
http://archinte.ama-assn.org/content/vol168/issue1/index.dtl

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An Assessment of Urologists Training and Knowledge of Energy Based Surgical Devices

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By: Lehman, DS; Phillips, CK; et al
BJU International

A questionnaire was distributed to 1000 urology residents, fellows, and attending physicians. Despite widespread and growing use of ESI (energy-based surgical instrumentation), there is currently minimal formal training on energy modes and current energy devices being provided to urological surgeons. Both practicing and training urologists have a limited understanding of surgical energy modes and of existing ESI.

Additional Information:

An Assessment of Urologists Training and Knowledge of Energy Based Surgical Devices. By: Lehman, DS; Phillips, CK; et al. BJU International 2008.

http://www3.interscience.wiley.com/cgi-bin/fulltext/119879086/PDFSTART

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Inattentional Blindness: What Captures Your Attention?

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Institute for Safe Medication Practices (ISMP)

The amount of information that can be taken in by our senses is limitless. But the brain has very limited resources when it comes to attentiveness. Accidents happen when attention mistakenly filters away important information and the brain fills incorrectly fills the gaps. This article describes visual attentiveness, or what captures your attention. It is shaped by four factors, conspicuity, capacity, expectation, and mental workload and task interference.

Additional Information:

Inattentional Blindness: What Captures Your Attention? ISMP Medication Safety Alert! February 26, 2009.
http://www.ismp.org/Newsletters/acutecare/articles/20090226.asp

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LabNet

Revelations in In Vitro Diagnostic (IVD) Device Labeling - Proactive Prevention of Adverse Events by Informed Decision Making

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By: Simon, K; Kondratovich, M
FDA Office of In Vitro Diagnostics

Picture this: a representative from a large, reputable company has just finished training your staff in the use of their best-selling IVD device. Each technician has passed their proficiency test and has been cleared by the company to run the assay. The instrument has been installed and calibrated and all validation runs are complete. You are ready to go, right? Wait! Don’t forget to carefully read the package insert; this document provides tips to help you ensure that any new IVD device will not be misused in your laboratory.

In clearing or approving a device, FDA must consider (among other factors) “the conditions of use prescribed, recommended, or suggested in the labeling of the device” (21 CFR 860.7). What does this mean? In short, an FDA cleared or approved device might not be safe and effective if it is not used in accordance with the device labeling. What is the pertinent information for you, the laboratory manager or the technician performing the test, to look for in each section of the labeling to help protect patients from adverse events?

Intended Use
This is the most important information in the device labeling, as FDA’s review of an IVD device is driven by the intended use of the device. FDA only evaluates, clears and approves a device for the intended use as stated in the labeling. This is the first item to look at in determining how to utilize the test appropriately in your laboratory. Important points to check in the intended use are the appropriate patient populations (target population), sample types, diseases or conditions (target condition), etc. For example, a test cleared for use in patients with signs and symptoms of a disease or disorder may have very different performance characteristics if it is used on asymptomatic patients. Off-label use in asymptomatic patients of IVD tests intended for symptomatic patients typically results in a relatively high proportion of false positive to true positive test results (in some cases, false positives can outnumber true positives 1 by several fold) – leading to inappropriate diagnosis and treatment of patients. Another common example would be a test where performance characteristics have been established in a pediatric or adult population, but not both. IVD test performance can vary greatly between adults and pediatrics, an example being IVD tests for influenza A/B. Pediatric patients seen by clinicians for influenza infections tend to present with significantly higher levels of virus in their nasal secretions than adults. Therefore, a test cleared only for use in a pediatric population may give a very high number of false negative results in an adult population, leading to a delay or absence of intervention, which could cause severe morbidity and mortality, particularly in elderly patients. It may be helpful to make certain the physicians that utilize your services understand the intended use of each test offered by your laboratory upfront, by having a comprehensive list of tests offered, which describes the intended use of each test. If a physician unknowingly orders a test for a specimen type which is not listed in the intended use, it may be important for you to inform the physician that the test has not been cleared for that specimen type (referencing your test menu with the intended use).

Limitations
This section of the labeling contains key information about how the device may be limited in its ability to provide accurate results. What? FDA clears and approves IVD devices that may, at times, give false positive or false negatives? Yes. In fact, most do, to a certain extent (if you read the device labeling, it is extremely rare to find an IVD device that has perfect performance). Understanding the limitations of a device will help you to minimize the occurrence of false positive or false negative results and subsequently improve patient care. Typically, the limitations highlight key results from performance studies, or indicate where information on performance is lacking. For instance, a serology assay that has been shown to cross react with rheumatoid arthritis antibodies will likely have a limitation that the device should not be used in arthritic patients and consequently is probably not a good choice for a laboratory with a large proportion of specimens from an elderly population. Certain limitations may also arise from specific technological characteristics of a device. For instance, a device that has a qualitative output may have a limitation stating that the numeric value reported does not correlate with analyte levels present in the sample. The limitations section may indicate specific patient subpopulations for which device performance has not been established, or has been determined to be unsatisfactory, at a greater level of detail than can be found in the intended use. The limitations may also indicate variations on the targeted analyte that may render the analyte undetectable, such as a particular strain or mutant of an infectious organism. A common type of limitation is for patients with a disease or condition that affects (or may affect) the performance of the device, such as the arthritis example above. In cases where it is unlikely that the laboratory will be aware of such a disease or condition in patients, it may be beneficial for the laboratory to report the test limitation to clinicians along with each patient result.

Warnings and Precautions
Here is where you can determine the type of information and training needed to ensure that the test can be conducted safely in your laboratory. Check to ensure that your laboratory and personnel are equipped to handle the hazardous materials required to run the IVD device.

Procedure
The detailed procedure in the device labeling gives key information about how to perform the test correctly. Be wary of abbreviated protocols when an IVD test is first being used; it is important to check to ensure consistency between the procedure in the device labeling and any abbreviated protocols that might be provided by the company. It is important to monitor equipment to ensure that the test is performed within the time and temperature ranges recommended in the procedure – control materials alone may not ensure that the assay was run properly.

Quality Control
Not all quality control materials are created equal. You should be able to extrapolate from the quality control section the information needed to determine if the quality control (QC) materials provided or sold for use with the IVD device are suitable to satisfy your laboratory’s local, state and federal requirements for QC materials. In many cases the controls provided are only intended to monitor for substantial reagent failure, and are not intended to monitor precision near the assay cutoff. This is why it is important to check control information, including analyte levels and sample matrix. Look to see if additional controls are recommended for you to supply yourself, or purchase from another vendor. Also check this section for QC procedures, frequency, and recommended corrective actions when controls fail. If recommendations sufficient for your laboratory are not found in the labeling, you will need to establish them according to your own laboratory policies and procedures.

Interpretation of Results
This section of the labeling will give recommendations on how test results should be interpreted and reported to physicians. Consider the following when reviewing the Interpretation of Results:

Equivocal Zones
The Interpretation of Results section may include information on an equivocal zone.
Equivocal zones are put in place for many assays, due to less than perfect precision near the medical decision point(s). An additional factor that may come into play when adding an equivocal zone to an assay are the number of clinical specimens that fall close to the medical decision point(s), within the range of imprecision. Recommendations for retesting samples with equivocal results are typically made when such retesting improves the overall performance of the assay. Recommendations for testing a freshly collected specimen as a follow-up to an equivocal result are typically made when time is expected to affect levels of the measured analyte (as in serology assays), and such recommendations should be reported to physicians along with the equivocal assay result.

Additional Diagnostic Procedures
The Interpretation of Results section may include recommendations for additional testing based upon the initial test results, for example, confirmation of positive or negative results by additional diagnostic procedures. Recommendations for additional testing are typically put in place due to low clinical sensitivity and/or specificity, and as such should not be ignored, unless it is determined that a false positive or false negative result would have a negligible impact on the clinical management of the patient.

Clarity
FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) strongly encourages feedback from a laboratory (or physician) if they become aware of any general confusion on the part of physicians regarding the significance of IVD test results (as reported per the recommendations in the Interpretation of Results section of the labeling). This could increasingly become an issue as more IVD devices are developed that measure multiple analytes simultaneously. For example, the significance of multiple human genetic mutations may be difficult to summarize in the product labeling, such that a physician might have trouble interpreting the reported results of a multiplexed genetic test. Since physicians often contact laboratories first with these types of questions, the laboratory may wish to consider ensuring that its personnel are knowledgeable about the labeling recommendations on how to interpret test results. Also, the laboratory is in a good position to notify FDA of any recurrent difficulties in interpretation of assay results and should feel free to ask FDA/OIVD any questions that are difficult to answer. OIVD contact information and other general information can be found on our website 2

Invalids
If a test has a relatively high invalid rate, this would likely be indicated in the labeling, typically in the interpretation of results, or in the limitations.

Performance Characteristics
When trying to decide between different IVD devices for your laboratory, you will probably consider cost and convenience, but ideally, performance characteristics will weigh heavily in your decision. The following are some tips for interpreting performance characteristics as reported in IVD device labeling.

Sensitivity and Specificity vs. Percent Agreement
The performance of IVD devices are often measured against imperfect standards or comparators. Performance is reported as clinical “sensitivity” and “specificity” only in cases where (among other considerations) the comparator is considered a “gold-standard,” which can be defined as the best available method for determining the true clinical status of the patient. It is important to note that even a gold-standard is likely to be imperfect and can change with the development of new technologies. A gold standard is clearly the preferred method for reporting estimates of diagnostic performance, but in many cases this is not available as a comparator. In these cases, performance is reported against a non gold-standard comparator as “positive percent agreement” and “negative percent agreement” in lieu of “sensitivity” and “specificity” 3 . The problem with performance estimates reported as positive percent agreement and negative percent agreement is that the true clinical status of each patient is unknown. Take an example where a positive test result indicates the patient is positive for antibody to the hepatitis A virus. In such a case, if a new hepatitis A antibody IVD device reports 95% positive percent agreement to a comparator, the new device can not be interpreted as detecting 95% of all individuals with hepatitis A antibody. Why? The comparator assay is imperfect. The comparator may, for example, miss 7% of hepatitis A antibody positive individuals. Therefore, the new assay’s clinical sensitivity is essentially unknown because all the hepatitis A antibody positive individuals have not been correctly identified in this evaluation. This is why performance in this case is reported as positive percent agreement and not sensitivity.

Confidence Intervals
Take note of the confidence intervals reported along with estimates of clinical sensitivity, specificity and percent agreement for an IVD device. Not all point estimates are created equal. Depending on the size of the study population and prevalence of the disease or condition of interest, the performance estimates reported can vary significantly in their level of confidence. Simply stated, if a test identifies 10 out of 10 true positive results correctly, your level of confidence that the test is 100% sensitive is much lower than if the test identified 100 out of 100 true positive results correctly. The true sensitivity may be as low as 72.3% (10/10) vs. 96.3% (100/100).

Be wary of discordant resolution
For specimens where a device and its comparator are discordant (e.g., one result is positive and the other is negative), the results of a third comparator method may be footnoted in performance tables. However, performance expectations are never changed based on the results of discordant resolution, because this type of analysis by default will always enhance performance estimates. Since only discordant specimens are undergoing additional testing, there is nothing to lose and everything to gain in estimates of performance. If a third comparator is performed on every specimen in the dataset, and if the performance characteristics of the third comparator are known, then adding a third comparator is truly informative.

Conclusion
Choosing the best IVD device to meet the needs of both patients and physicians is only possible if you read and carefully analyze the labeling of each test that your laboratory offers. Most importantly, good communication between the clinical laboratory and physicians regarding the appropriate use of tests offered by the laboratory can help make significant advances in the quality and cost-effectiveness of patient care. Periodically communicating with your ordering physicians regarding the importance of limiting tests ordered to the appropriate patient populations is one critical way of improving patient care. Relating key information, such as limitations, from IVD package inserts to ordering physicians is another. If you have not already done so, it may be beneficial to consider putting a program together for your laboratory that highlights key information for each test that you offer. Without it, the tests offered by your laboratory could easily be misused and misinterpreted. If you notice that such information is not being utilized by your customers, a periodic reminder of the availability of the information would be prudent.
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1 False positive result is a positive test result for a subject in whom the target condition is absent (by clinical “gold-standard”).
False negative result is a negative result for a subject in whom the target condition is present.
True positive result is a positive result for a subject in whom the target condition is present.
True negative result is a negative test result for a subject in whom the target condition is absent.
Please see CLSI document EP12-A2 “User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline-Second Edition”, 2008 for more details

2http://www.fda.gov/cdrh/oivd/index.html

3For FDA’s detailed perspective on reporting diagnostic test results, see the FDA guidance document entitled “Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests” found at: http://www.fda.gov/cdrh/osb/guidance/1620.pdf

Additional Information:

Revelations in In Vitro Diagnostic (IVD) Device Labeling – Proactive Prevention of Adverse Events by Informed Decision Making. By: Simon, K; Kondratovich, M. FDA Office of In Vitro Diagnostics.

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Factitious Biochemical Measurements Resulting from Hematologic Conditions

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By: Dalal, BI; Bridgen ML
American Society for Clinical Pathology

False laboratory results often lead to unnecessary testing or treatment. This brief review of false biochemical results due to pre-existing hematologic conditions focuses on the mechanisms underlying the false results and suggests ways to prevent them.

Additional Information:

Factitious Biochemical Measurements Resulting from Hematologic Conditions. By: Dalal, BI; Bridgen ML. American Society for Clinical Pathology. 2009.
http://ajcp.ascpjournals.org/content/131/2/195.full.pdf+html

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KidNet

Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc.

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class 1 Recall of specific lots due to complaints received about difficulty inserting the device used to place the tracheostomy tube into the windpipe (obturator), and/or a suction tube (catheter) into the tracheostomy tube. This problem may require that the tracheostomy tube be removed and replaced.

Additional Information:

Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc. FDA MedWatch Safety Alert. March 10, 2009.
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Shiley

Class 1 Recall: Covidien Inc., Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube. FDA Recall. January 14, 2009.
http://www.fda.gov/cdrh/recalls/recall-011409.html

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FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report

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FDA Press Release
Based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies. However, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, FDA has initiated studies to determine whether BPA is leaching into patients.

Additional Information:

FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report. FDA Press Release. October 28, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116973.htm

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KidNet - Get Set for Pediatric Patient Safety

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By: Suzanne Rich, RN, MA, CT
FDA/CDRH/OSB Division of Safety Partnerships

KidNet is a specialty subnetwork of FDA's Medical Product Safety Network (MedSun). It is focused on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric patient populations, especially those occurring in neonatal and pediatric intensive care units (NICUs and PICUs).

Currently, 37 MedSun hospitals are participating in KidNet. Just over half of these are MedSun pediatric hospitals; the rest are MedSun hospitals with NICUs and PICUs. We launched KidNet in June 2007.

The data discussed in this article represent reports received in 2008.

For calendar year 2008, we received 125 reports on device–related adverse events from MedSun KidNet hospitals.

This bar graph illustrates the number of KidNet reports received by quarter.  These reports were submitted by KidNet participant sites over the 2008 calendar year.  The 125 KidNet reports have been grouped by quarter (1st quarter, 2nd quarter, 3rd quarter, 4th quarter). The x-axis corresponds to quarter; the y-axis corresponds to the number of reports.  Left to right description of image: of the 125 KidNet reports received in 2008, the light purple data point shows that 21 KidNet reports were received in the 1st quarter.  The burgundy data point shows that 32 KidNet reports were received in the 2nd quarter.  The yellow data point shows that 25 KidNet reports were received in the 3rd quarter.  The tallest data point, depicted by a light blue bar shows that 47 KidNet reports were received in the 4th quarter.

As part of the larger MedSun network, KidNet emphasizes the importance of recognizing and reporting device related adverse events associated with patient, family member, or healthcare provider death or serious injury, and in recognizing and reporting problems representing ‘potential for harm’ and ‘close call’ events. The majority (96%) of reports from KidNet in 2008 involve device-related problems described as minor harm, potential for patient harm, or close call events.

Two percent (2%) of the reports indicate that intervention was required to prevent permanent impairment or damage (FDA’s definition of serious injury), and 2% of the reports were about a patient death.

This pie chart illustrates the number of reports by event type submitted by KidNet participant sites in 2008.  The 125 reports are categorized by event type, specifically by the categories of:  product problems, serious injury, and death.  Of the 125 reports, 119 reports were submitted as product problems, depicted by a light purple pie wedge.  3 reports were submitted as serious injury and 3 reports were submitted as death, which are depicted by burgundy and yellow pie wedges, respectively.

There are 3 reports (2% of 2008 KidNet reports) indicating intervention was required to prevent impairment or damage (serious injury events): (1) an event involving a peripherally inserted central venous catheter (PICC) that was noted to be sheared, which then migrated; the patient was taken to the cardiac cath lab for percutaneous removal, (2) an event involving an IV tubing set with the single lumen central line broken above the connector on the Huber needle resulting in explant of the line and replacement with a new one and, (3) an event associated with a life-threatening outcome involving a programmable ventriculoperitoneal shunt with massive over drainage several weeks after placement. The programmable setting of the shunt valve was checked, found to be open at the lowest setting, and was immediately changed to ‘closed.’ A CT scan a few days later showed improvement in the size of ventricles and slight decrease in the size of subdural hematoma.

The 3 reports (2% of 2008 KidNet reports) associated with patient deaths include an event of a high frequency oscillating ventilator that was being used on the patient that stopped oscillating and lost all pressures, requiring bagging of the patient – the patient later died. The second event involves an infusion pump that was accidentally programmed for 68 ml/hour instead of the ordered rate of 6.8 ml/hr. resulting in overinfusion of total parenteral nutrition (TPN). The third event is associated with a cardiac monitor placed on a baby and when the parents came in they found the monitor turned off. When the monitor was checked by turning it back on, the monitor went blank again, without an alarm sounding, and it was later found the cord had worked itself loose. No further information is provided about the device problem contributing to the patient death.

The 125 KidNet reports reference 151 devices, of which there are 46 different types. The number of devices is greater than the number of reports as more than one device may be referenced in a report. The 46 reported device types have been grouped by clinical medical specialty as defined in the listing below for the chart that follows.

(1) IV products – (PICCS, ports, needles, syringes, tubing, pumps)

(2) CV products – (cardiovascular monitors, EKG electrodes, cardiopulmonary bypass devices, implantable cardiac defibrillators, external defibrillators, external pacemakers, vascular hemostasis devices)

(3) GI/GU products – (enteral feeding pumps & GI tubes, dialysis delivery systems, and urinary and hemodialysis catheters)

(4) Respiratory products – (tracheobronchial suction catheters, ventilators, cannulas, humidifiers, respirators, regulators)

(5) All others - (general hospital, general surgery, neurology, IVD devices)

This bar graph illustrates the number of reported medical devices by type in 2008 KidNet reports. The 151 devices reported have been grouped by clinical medical specialty. The x-axis corresponds to type of device; the y-axis corresponds to the number of devices reported.  Left to right description of image: of the 151 devices reported in 2008, the tallest data point, depicted by a light purple bar, shows that 76 reports involve Intravenous (IV) devices.  The burgundy data point shows that 22 reports involve Cardiovascular (CV) devices.  The yellow data point shows that 22 reports involve Gastroenterology/Urology Devices (GI/GU) devices.  The light blue data point shows that 17 reports involve Anesthesia/Respiratory (AN/Respiratory) devices.  The dark purple data point shows that 14 reports involve All Other device types.

Reported patient demographics include patient ages and gender, of which information was provided for 116 of the 125 reports.

This pie chart illustrates the number of 2008 KidNet reports that specify patient gender.  The 116 reports are categorized by gender, specifically by male and female.  Of the 116 reports, 69 reports involving male patients were submitted, which are depicted by a light purple pie wedge.  47 reports involving female patients were submitted, which are depicted by a burgundy pie wedge.

Patient ages that were provided in the 125 reports range from 1 day to 21 years. The chart below groups patient ages by the pediatric subpopulations specified in the Guidance for Industry and FDA Staff: Pediatric Expertise for Advisory Panels at http://www.fda.gov/cdrh/ode/guidance/1208.html. Note that there are more patient ages than reports as reports may contain events with more than one patient.

This bar graph illustrates the number of reported patient ages by pediatric subpopulation in 2008 KidNet reports. The 130 reported patient ages have been grouped by pediatric subpopulations.  The x-axis corresponds to pediatric subpopulation; the y-axis corresponds to the number of patient ages reported.  Left to right description of image: of the 130 reported patient ages in 2008, the light purple data point shows that 47 reports involve newborn patients (0-30 days).  The tallest data point, depicted in burgundy, shows that 51 reports involve infant patients (30 days-2 years).  The yellow data point shows that 16 reports involve child patients (2 years-12 years).  The light blue data point shows that 16 reports involve adolescent patients (12-21 years).

Although the focus of KidNet is on medical device-related adverse events occurring in the NICU or PICU, reports on events occurring in other areas of the hospital are welcomed. Information on the area where the reported event occurred was provided in 83 of the 125 reports; most reports list ‘critical care.’ A large number of reports indicate ‘other’ as the event location. Recent programming changes provide MedSun KidNet reporters with an option of specifying NICU or PICU as the area where the event occurred.

This bar graph illustrates the number of reports by patient care area, or event location, submitted by KidNet participant sites in 2008.  The 83 reports, which specify adverse event location, have been grouped by 5 different patient care areas, specifically:  critical care, other, patient room, operating room, and skilled nursing unit.  The x-axis corresponds to patient care area; the y-axis corresponds to the number of reports.  Left to right description of image: of the 83 KidNet 2008 reports with patient care areas specified, the tallest data point depicted by a light purple bar shows that 36 reports list critical care as the patient care area.  The burgundy data point shows that 25 reports specify patient care areas other than those depicted in the graph. The yellow data point shows that 15 reports indicate the patient care area as the patient room.  The light blue data point shows that 6 reports cite the operating room as the patient care area.  The dark purple data point shows that 1 report identifies a skilled nursing unit as the patient care area.

Information on who was operating the device at the time of the event is available in 73 of the 125 reports; most reports (52) indicate ‘nurse’ as the device user.

This bar graph illustrates the number of reports by device users - who was operating the device at the time of the event – in 2008 KidNet reports. Of the 125 KidNet 2008 reports, 73 reports indicate the device user.  The x-axis corresponds to specific device user; the y-axis corresponds to number of reports.  Left to right description of image: of the 73 reports indicating device user in 2008, the tallest data point, depicted by a light purple bar shows that 52 reports specify nurses were operating the reported device at the time of the event.  The burgundy data point shows that 9 reports show that doctors were operating the reported device at the time of the event.  The yellow data point shows that 8 reports identify allied health providers as the user operating the reported device at the time of the event.  The light blue data point shows that 4 reports state patients were operating the reported device at the time of the event.

The goals of KidNet are:

(1) to improve the recognition, reporting, and understanding of device-related adverse events occurring with pediatric patients, especially those in NICUs or PICUs, and

(2) to develop a clinical community to amplify signals of actual or potential medical device problems affecting NICU or PICU patients recognized by FDA or KidNet participants to facilitate timely interventions to address actual and potential device-related problems during clinical use.

This concept is based on collaboration and communication between FDA, KidNet participants, and device manufacturers, in order to better understand device safety and to identify solution and prevention strategies to address identified problems.

To this end, KidNet sponsored two Roundtable webcasts in 2008. The May Roundtable, Recently Reported Safety Issues Involving Pediatric and Neonatal Patients discussed safety issues identified in recently reported adverse events from MedSun NICUs and PICUs including: problems encountered during the administration of supplemental oxygen using head hoods, incubator and infant warmer fires, and bedside monitor failures.

The November Roundtable, Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events featured Luer connector experts from FDA and Beaumont Hospitals discussing major factors that contribute to Luer-connector misconnections and examples of adverse events associated with these misconnections. Presentation slides and audioconference transcripts are available for these, along with other MedSun and KidNet programs, at http://www.fda.gov/cdrh/medsun/conference.html.

The following are 2 examples of device-related problems reported through KidNet in 2008 that represent just a few of the many successes in problem identification, information sharing, and solution strategies developed by device users, FDA, and manufacturers to address and improve the safety of medical device use in the clinical setting.

Cardiovascular Monitor: Three reports from the same KidNet hospital cite problems with a single manufacturer’s model cardiovascular monitor screen spontaneously going blank while in use on patients in the neonatal intensive care unit (NICU). No patient injuries were reported to be associated with this problem; however, the hospital reported the problem due to the potential for harm to the patient. FDA’s follow-up with the KidNet hospital’s nursing and biomedical departments, along with FDA follow-up with the manufacturer resulted in the firm’s identification of a root cause. As a result of this report and information sharing between the hospital, FDA, and the manufacturer, the firm issued a Dear Customer Letter to current customers with the subject device model to alert them of the monitor blanking problem and the availability of replacement parts.

Central Venous Catheter: A MedSun KidNet report describes problems encountered during an attempted catheter flush prior to placement in the patient because the catheter lumen was obstructed. Information sharing between FDA and the reporter, as well as FDA follow-up with the manufacturer, resulted in the firm identifying the catheter lumen was obstructed due to debris during the manufacturing process. The manufacturer has made changes to address the problem.

If you become aware of problems with devices indicated for use with neonatal or pediatric patients that fail or don’t perform as intended, or represent a potential for harm, please report these events through your MedSun representative if you’re a member of KidNet or MedSun, or through your hospital’s reporting policy. If you are not affiliated with a hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/medwatch/index.html. Together, we can make recognition and reporting of medical device-related adverse events a model for patient safety.

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period January 1 through January 31. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


GENERAL HOSPITAL

Device: Bag, Enteral Feeding
Manufacturer: Covidien Kendall
Brand: Kendall (Kangaroo Enteral Feeding Bags)
Cat #: REF 773662
Other #: barcode 00388847736628

Problem:

Our new tube feeding sets will not prime properly. Covidien redesigned the set to change the connection tubing so that it cannot be used with a Luer lock syringe. This change eliminates the chance that a clinician might hook the patient’s feeding tube to an IV infusion by mistake. Since the new sets arrived in the units, the staff members have reported issues with priming the tubing. The product representative has visited each unit that reported a problem, re-educated staff on the proper technique and collected some sets that the staff deemed defective. Nonetheless, the problem persists. The staff states they have had to try two or three sets to find one that works. They must waste the feeding product as well as the set each time. The manufacturer has now pulled our existing inventory and replaced our product stock.

Device: Tubing, Iv
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Smartsite Needle-free Valve PortAdd-on Burette Set
Cat #: 82114E
Problem:

A patient was receiving chemotherapy when an Alaris pump indicated air in line. On inspection by the nurse, it was noted that there was air in line all the way from below the drip chamber (which was half full) to the pump. The line had to be cleared of air.
======================
Manufacturer response for burette, Smartsite Needle-free Valve PortAdd-on Burette Set
======================
The rep was on site and is supplying us with a different type of buretrol to try. The staff report the buretrols are hard to spike. The rep feels that possibly the intake valves are not straight and are allowing air in.

Device: Set, Administration, Iv
Manufacturer: Alaris Medical Systems, Inc.
Brand: Latex -free Add-on Burette Set
Cat #: 82114E

Problem:

A nurse was priming a patient's chemotherapy tubing with normal saline when it was noted that there was fluid leaking from a hole in the bottom of the Alaris buretrol. Pharmacy was called. The pharmacist was able to re-spike the chemotherapy bag with a new buretrol. The chemotherapy was then administered as ordered without further incident.

GASTROENTEROLOGY & UROLOGY

Device: Ultrafiltration Drain Bag, 7 Liter
Manufacturer: B. Braun Medical, Inc.
Lot #: 7210511
Cat #: 07M18 or 08G18

Problem:

There was a leak from the side of the Diapact ultrafiltration drain bag. The spot was on the side of bag at the top fold, about two-thirds up. There were a number of reports involving the seven liter CRRT drainage bags from this facility where a bad lot was received. The mfr. had identified the bad lot in these old reports and had replaced them, but the bags continued to resurface. Somehow, the facility was re-supplied the same lot that was bad. B.Braun denied receiving reports of this problem with the defective bags from any other user facility.

Device: Hemodialysis Machine, Crrt/cvvh
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Problem:

Last summer, RN was taking care of patient with CRRT Prismaflex running continuously. There were reported "access pressures" issues with the patient and all possible nursing interventions were carried out to attempt to correct problem. The nurse then reported that the machine alarmed with a malfunction of the effluent scale. The machine shut itself down and would not allow any retesting to occur. The machine was sent to Biomed for inspection and a replacement Prismaflex machine was brought in to continue with the ordered therapy.

======================
Manufacturer response for Hemodialysis Unit, Prismaflex Machine
======================
Gambro assisted with testing on site and serviced the device at their location.

Device: Tubing, Insufflation
Manufacturer: Stryker Endoscopy
Brand: Pneumosure
Model #: 620-040-690
Lot #: 069408D
Cat #: 620-040-690
Problem:

Insufflation Tubing disconnecting at grey end (Distal end -connector to machine) causing loss of Abdominal Insufflation, which disrupted view during procedure. Will not reconnect and seal. Continues to lose pressure despite multiple reattachment attempts. Connection to trocar end also becomes disconnected when maneuvering telescope through the trocar. Connectors at both ends of insufflation tubing are lacking adequate connection.

Loss of insufflation disrupted surgeons view during hernia repair. Multiple reinsufflation attempts extended procedure. Fortunately, there was no bleeding at the time, but loss of insufflation at a more critical juncture of the procedure could have resulted in opening the patient. We believe this is a safety issue requiring immediate resolution.

Device: Hemodialysis Machine
Manufacturer: Fresenius Medical Care North America
Model #: 2008K
Cat #: 2008K
Problem:

Patient had bleed out of at least 1.5 liters of blood from a leaking venous connection that had become slightly disconnected. Further investigation found that patient had been placed on their back. Patient's wife had covered up their access site, and when the venous pressure alarm condition was reset there was not a confirmation of the venous pressure by staff. Apparently, the alarm condition was reset at an unknown pressure. Machine continues to operate at this unknown pressure once reset without any further notification to operator. Patient's wife called attention to the patient. The treatment was terminated. EMS was activated and the patient was moved to the floor. One and half liters of normal saline was pushed and CPR was started at the same time. Within four compressions the patient became responsive. At this point the ER staff from the hospital responded and transported the patient to the hospital ER for further evaluation and care. The machine operation was tested and appeared to operate normally. A call was placed to Fresenius Medical Care North America to report the problem. Further follow-up will be reported to Medwatch. Spoke with technical assistance to further evaluate testing methods. Machine does have a blood sensor that should give an alarm condition when at a zero pressure. This sensor was not tested at the time of incident. On another date I was called to the facility and had the charge nurse test this sensor with a zero pressure, and it appeared to still have almost a twenty second delay before the venous clamp engaged and the blood pump stopped.

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Manufacturer response for Dialysis Delivery System
======================
Further follow-up will be reported to MedWatch.

Device: Catheter Tray, Foley
Manufacturer: C.R. Bard Inc.
Brand: 100% Latex Free Foley Tray With Bard Ez-loc Sampling Port 16 Fr
Lot #: NGSH1823
Problem:

Unable to remove the foley catheter after balloon was fully deflated. We reviewed the issue with the manufacturer and were told that we should not be inflating/deflating the balloon prior to insertion, which we were doing. We sent instructions to the nursing floors to discontinue the practice of inflating/deflating prior to insertion. We contacted the company and were told that the problem was that the foley should not have been inflated prior to insertion, which was a common practice with earlier catheters.

Device: Tubing, Hemodialysis
Manufacturer: Medisystems Corporation
Brand: Readyset Hemodialysis Blood Tubing Set
Lot #: 8075108
Other #: D3-9642M9795

Problem:

Upon starting a dialysis treatment, the arterial transducer line tip was cracked and air was in the line. Treatment was stopped just as air was reaching dialyzer. Arterial pressures became high as blood was in the transducer line. Venous needle only had saline in line. System was disconnected from patient. New lines and dialyzer was primed and recirculated before the start of the treatment.

ORTHOPEDIC

REPORT HAS IMAGES/PHOTOS
Device 1: Implant, Acetabular Cup, Resurfacing System
Manufacturer: Smith & Nephew, Inc.
Brand: Birmingham Hip
Model #: 74120160
Lot #: 086149
Cat #: 60 mm

Device 2: Implant, Femoral Head, Resurfacing System
Manufacturer: Smith & Nephew, Inc.
Brand: Birmingham Hip
Model #: 74123152
Lot #: 08DW16616

Problem:

A Smith and Nephew Birmingham Hip Resurfacing System was being implanted in the patient. There is a range of new sizes and packaging that were just released. This was the first time using "new" product. The new product is color coded to indicate compatible size combinations. Mismatched components were placed in the patient. "Old" product is not color coded.

The surgeon expressed that he took additional steps such as meeting with the rep prior to the procedure to discuss the new implant sizes and what he expected to use for the case. He also expressed concern that there could be a mix-up as 2 products have the same numerical size but one fits a certain size head and another fits a different size head. He also felt the labels could be designed better to have the key information in the largest font. On these labels for example, the expiration dates are in larger font, and in this case were the same, so they gave the appearance that they "matched." The outer box label has some of the information on size compatibility on the face of the box and some on the edge, so the box has to be moved to see all of the key information. The label design could be improved to have key information such as compatible sizes listed in a largest font.

When new products/sizes come out, the existing stock should be marked for compatibility with the new sizes. There was no color coding on the 60mm cup. We would recommend label redesign using Human Factors principles to make the most important information the largest font. See images.

This picture displays the bottom of the box from the new labeling of a 60 mm acetabular cup from the Smith and Nephew Birmingham resurfacing hip system.  This picture has useful information to the user that can only be obtained if the user remembers to look at the bottom of the box.

This picture depicts the side of the box from the new labeling for a 60 mm acetabular cup from the Smith and Nephew Birmingham hip resurfacing system.  The labeling is surrounded by a brown rectangle to emphasize that brown labeling for an acetabular cup should go with brown labeling for a femoral head.

This picture has two different labels in it for two different products.  The top label is the old labeling for a 60 mm diameter acetabular cup from the Smith and Nephew Birmingham hip resurfacing system.  It has an expiration date of 2013-04 and states that it should only be used with a 54 mm size head. The bottom label depicts the new labeling for a 52 mm diameter femoral head.  The labeling is surrounded by a brown rectangle to emphasize that brown labeling for a femoral head should go with brown labeling for an acetabular cup.  It also has an expiration date of 2013-04.  Considering the old labeling did not have brown color on it and there was no compatibility chart for the user to refer to, the user thought that these two products from picture three were compatible because the expiration dates are the same and in a large font.



Device: Reamer
Manufacturer: Synthes USA, Inc.
Brand: Reamer Irrigator Aspirator (Ria)

Problem:

When ambulating from the commode the patient felt a snap in her left femur and lowered herself to the ground. X-rays showed a left subtrochanteric femur fracture. The injury was repaired with an intramedullary gamma nail placement to the left femur. The left femur is the site of the bone graft harvest performed using the Synthes RIA bone grafting system.

Device: Impactor, Femoral
Manufacturer: Smith & Nephew, Inc.
Brand: Journey
Model #: 74012811

Problem:

OR discovered the plastic on the Smith and Nephew femoral implant impactor is chipped and cracked. This is the second event involving the same type of impactor. This report is being submitted for documentation purposes only. The company is aware of the problem and is addressing the issue.


GENERAL & PLASTIC SURGERY

Device: Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Model #: ACE36E

Problem:

Harmonic ACE curved shears received pad damage during intraoperative use - appeared melted. Surgery was laparoscopic supra-cervical hysterectomy. The sales rep was present and took the damaged product.

Clinical Engineering was called by the OR and informed that the return plate of the disposable shears had been damaged during the case. There wasn't any harm, but they wanted the device checked to make sure it is working properly. The salesman took the damaged disposable. He retrieved all 4 hand controllers because there wasn't any indication as to which was used. Completed safety and functional tests of the generator as per manufacturer's specifications. Completed functional test on hand controllers. Phase Margin (Hz) range should be between 170-247. Impedance (Zr) range should be between 15 - 40. No issues identified. All hand controllers were operating within tolerance. Clinical Engineering called the Ethicon sales rep. He explained that the incident was caused by the hand controller being activated after the shears had cut through tissue causing both sides to touch. If this happens throughout the case it could have caused damage to the return plate.


CARDIOVASCULAR

Device: Introducer
Manufacturer: C.R. Bard
Brand: Bard Ssv Split Sheath With Valve Introducer System
Lot #: 526744
Cat #: 808700

Problem:

CST was scrubbed in and setting up for an implant. While the patient was being prepped she went to flush the safe sheaths she was given. She noticed the syringe that she picked up had a brown and sticky substance on it, which was not related to anything on the tray. She then had RCES called and asked to come to remove the product. RCES then had both sheaths removed, told the staff to reopen another tray, discarding the contaminated tray and equipment and asked the scrub tech to re-gown and glove. Nurse then had all the 7 FR sheaths from that lot # pulled and set aside as well as informed the company of the issue.

Device 1: Defibrillator, External
Manufacturer: Medtronic Emergency Response Systems
Brand: Physio-control Lifepak 12
Model #: LP12

Device 2: Defibrillator, ICD
Manufacturer: Medtronic Inc.
Brand: Virtuoso

Problem:

A code was called on a patient that was in SICU. The defibrillator pads were placed on the patient and the patient was being monitored by both the LP12 defibrillator and the patient monitor. Chest compressions were being administered and the staff reported that the defibrillator delivered a shock to the patient and attending staff without the shock button of the LP12 being pressed. The patient’s rhythm was regained and the staff reported a tingling in her arms. In order to deliver a shock during proper operation of the defibrillator three options must be selected:
1) the energy level from 1 to 360 joules,
2) the charge button, and
3) the shock button must be selected to deliver the set energy level.
After the energy level is set and the charge button is selected, the defibrillator will have an audible tone until the shock button is selected. If the shock button is not selected within 30 seconds the defibrillator automatically resets without discharging.

The unit was bought to Biomed and tested fine. The field representative was called to test the unit and it tested fine. Upon further investigation, it was found that the patient had an implantable cardioverter defibrillator that had initiated a shock.

Comment from FDA: This report is featured to demonstrate the importance of communication.

Device: Monitoring System, Hemodynamic
Manufacturer: Witt Biomedical Corporation
Brand: Xper Information System
Model #: Xper
Other #: Software version 1.1.1.1291

Problem:

This is one of three systems having the same issue. The system samples invasive hemodynamic pressures, upon review of a sampled pressure measurement, the technologist edited the measurements. After a few minutes, the system changed the edited pressures back to the pre-edited measurements. The system doesn't print out accurate information. Staff has to make notes and dictate the actual results. Company has stated that it is a known software problem. Philips updated the software in September to: 1.1.1.1291 and again in January 2009 to version 1.2.1474 to resolve the latest issue.
======================
Manufacturer response for Monitoring System, Hemodynamic, XPER Information System
======================
This system performance issue is a potential patient safety issue. Philips has escalated our issues through their system and has agreed to an on sight meeting on in January to develop a plan of action to address these problems.

Device: Debrillator, ICD
Manufacturer: St. Jude Medical
Brand: Atlas Plus Vr
Model #: V-193

Problem:

Patient had LVAD (HeartMate-2) placement. His ICD was initially implanted for primary prevention of sudden cardiac death 3 years prior. Preoperatively his device was noted to have normal function, however immediately post LVAD implantation; we were not able to establish telemetry with his ICD. Failure of telemetry with St. Jude ICDs due to radiofrequency interference from Heart Mate II LVADs has been previously described in the literature (J.C. Matthews, M.D. et al., J Cardiovasc Electrophysiol, Vol. 18, pp 1107-1108, October 2007). The patient was seen and examined by an electrophysiology staff physician and deemed appropriate for a generator change to resolve this issue.


NEUROLOGY

Device: Holder, Head, Neurosurgical
Manufacturer: Ossur Americas
Brand: Halo Ring
Problem:

One specific lot of halo rings proved to be faulty in the manner that the threads on the ring were tapped too tightly to accept the ceramic pin without torque. There were a couple of previous patients that we noticed this problem on but the problem was so severe that the pins would not thread at all so the rings were not used and the pins never even got close to the patients head. No penetration. When this happened the ring was replaced and ensured that the pins threaded smoothly. The manufacturer has notified our facility that they have implemented several changes and corrective actions to their manufacturing process to correct this issue.

Device: Electrodes
Manufacturer: EMPI
Brand: Stimcare Carbon Cl Electrodes
Cat #: 199327-001
Other #: 814907 and 199327-001

Problem:

Patient underwent routine interferential electrical stimulation to left upper arm at 14 mA, same as previous treatments. She did not complain of pain during treatment, and no apparent skin abnormalities were noted upon removal of electrodes. However, the patient phoned the clinic later in the day reporting a blister from a burn in back of her left upper arm. She states it was about 2"x2", the same size as the electrode.

Of note, the re-sealable electrode storage bag had holes punched through the bottom portion of bag, to attach to it to the patients clinical chart (binder). The electrode pads had partially dried out in between treatments, due to the compromised integrity of the re-sealable bag. The dried electrodes had more electrical resistance, and are suspected to have arced and caused a thermal burn where it was applied to the skin. Our facility is no longer storing these bags in this manner. However, it is interesting to note that our facility had previously been storing bags in this manner for a long time, with no adverse outcomes. Clinical staff has also noted that the electrodes are not adhering as well as they previously did. The directions for use state that the electrodes can be used on the same patient for multiple treatment sessions, and that electrodes can be re-hydrated with a drop of water. Our facility is considering using new electrodes for each treatment, as a result of this recent incident.


ANESTHESIOLOGY

Device: Anesthesia Delivery System
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: Aisys
Other #: GE gas analyzer

Problem:

In the middle of the case the patient had to be bagged while the anesthesia delivery machine was changed out. The switchout involves a change in circuits and a Pedi-lite sensor. Anesthesiology was not aware that an upgrade for the carestation anesthesia delivery system was needed to take care of smaller children. We bought our machines at different times. The first ones were sent with the upgrade by mistake. The next order was not.

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Manufacturer response for anesthesia delivery system, Aysis
======================
Upgraded all of our machines to E-CAiOV so that they are standardized. Training given to staff on different circuits and sensors. Instructions for doing anesthesia on children smaller than 6 Kg

Device: Anesthesia Delivery Machine
Manufacturer: GE Healthcare, Inc.
Brand: Aisys Carestation
Problem:

Power switch caused machine to shut down. Had to change out machine in middle of surgery. This has happened in the past and GE related to us that they are having trouble with the power switch failing. GE advised us that when this is going to occur that the machine will give a visible display that it is going to shut down in 8 seconds. Then we should turn the switch to standby. Once the machine shuts down - wait for 10 seconds until compressed air is heard. Then the machine will reboot itself.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Ventricular Assist Devices

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A ventricular assist device (VAD) is a mechanical pump that helps a heart that is too weak to pump blood through the body. It is sometimes referred to as "a bridge to transplant" since it can help a patient survive until a heart transplant can be performed. A VAD is used to aid the pumping action of a weakened heart ventricle (a major pumping chamber of the heart). VADs were originally intended for short-term use to support failing hearts until donor hearts became available. Some VADs are now used for long-term (destination) therapy in severe heart failure patients who are not candidates for heart transplants [1].

Over the past 2 years, MedSun has received 19 adverse event reports associated with the Ventricular Assist Device. The reports represent 4 manufacturers: 15 reports for Thoratec Corp, 2 reports for Cardiac Assist Inc., 1 for Berlin Heart Inc., and 1 for ABIOMED Inc. The reports were submitted by 10 hospitals between March 6, 2007 and March 6, 2009. The most frequently reported device problems were:

• Battery problems (4)
• Pump failure (4)
• Electrical issue (3)
• Tubing Crack/Hole (2)
• Percutaneous lead fracture (1)
• Human factors (1)
• Device interaction with an Implantable Cardiac Defibrillator (1)
• Filling malfunction in the stroke volume limiter (1)
• Cannula disconnection (1)
• Console leak (1)

A total of 4 reports involved a patient death. Nine patients had no injuries or the injuries were unknown. The patient injuries listed below were reported in 6 of these 15 reports.

• 1 patient had delay of treatment
• 5 patients required additional surgery/removal of device

Of the reports that listed patient age, 1 had patient age listed as less than 21 years and 18 had patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 6 reports involved female patients, and a total of 12 reports involved male patients.

These MedSun reports contributed to FDA awareness of VAD device problems. The following recall, describing problems with the percutaneous lead, was for the Thoratec HeartMate II Left Ventricular Assist Device.

Recall number: Z-0496-2009
A recall was initiated on October 24, 2008 by Thoratec Corp for the HeartMate II Left Ventricular Assist System (LVAS), Model/Catalog Number 1355 and Model/Catalog Number 102139, all serial numbers.

The reason for the recall was that wear and fatigue of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump with the external system controller could result in damage that had the potential to interrupt pump function and require a reoperation to replace the pump.

FDA is currently looking into the other listed device problems described above.


[Note: The reports have been edited for clarity]
_________________







Ventricular Assist Devices
Device Device Identifiers Event Description
Thoratec/ HeartMate Catalog #: 1270/ Lot # 42526
The patient had the device implanted one year ago. Recently, the patient had low flows on device, was clammy and pale with Low BP, and had an acute drop in hemoglobin/hematocrit. The patient was admitted for concerns that the LVAD was failing.
Thoratec/No brand No Device Identifiers Blood pump of ventricular assist device failed.
Thoratec/Circulatory Assist Dual Drive Unit Model 2600 & Model 20002-0000-010 Surgeons were placing the BiVAD devices on the patient. The right VAD wiring and pneumatic line on the first module were placed and, when connected to the first Thoratec dual drive console, functioned as expected. However, when staff went to place the left VAD, it failed to function properly. A second Thoratec dual drive console was brought in with both top and bottom modules and was used to attempt to get the LVAD to work, while the RVAD remained on the first console. However, when both of the LVAD modules in the second console were connected to the patient, the device failed to function properly. After three hours of attempting to troubleshoot the problem, a portable console/driver device was tried, which appropriately operated both the RVAD and LVAD.

Upon inspection after the event, it was noted that there were incorrectly installed components on all three of the different Thoratec modules that were tried and failed to work. The first module was found to have an incorrectly wired solenoid valve which reversed the pressure and vacuum features of the module. Both the second and third modules were found to have incorrectly installed Humphrey valves, which also resulted in a reversal of the pressure and vacuum cycles in the LVAD. This produced insufficient filling and emptying intra-operatively. Though the perfusionists ran a Thoratec designed self pre-use check, the problem was not identified. Another contributing factor to this event was that during the preventative maintenance process in clinical engineering, staff members failed to notice (during the tubing verification check) that the incorrect lamp lit during that test. Careful and thorough analysis of the root cause of this incident revealed poor human factors design of the valve mechanisms. The solenoid valve installation problem on the first module was most likely caused by two of wires feeding into the module accidentally getting crossed. Internal examination of the component revealed a plethora of unlabeled wires used to connect the electric valve and control the Humphrey valve, which are all white and could easily be confused and erroneously crossed. The second and third modules were both found to have the Humphrey valves installed upside down. These valves are identical both right side up and upside down. They have no indication or directions as to the proper installation technique, and could easily be placed incorrectly within the device during regular PM routines. The manufacturer sent a representative to look at the device. There has been no response to date. However, after the root cause analysis, one action item to plan on working with the manufacturer on identifying human factors related issues in equipment design.
Thoratec/HeartMate Battery Lot # MG087009 Patient was going from batteries to Power Base Unit (PBU) in the clinic. When the patient was removed from the first battery, the patient got a red battery alarm, which then went to a red heart alarm in approximately two seconds. The pump was off for three seconds until the power was reconnected.
Thoratec/HeartMate II Lot # MG 264 The patient, who was at home, called the Ventricular Assist Device (VAD) Coordinator, and stated that there were three (3) light bars of power on the controller. Additionally, the patient noted that a yellow battery alarm occurred which was immediately followed by a red battery alarm. The patient said that alarms had been ringing for 5 minutes. The patient was instructed, per the VAD Coordinator, to change her power source. The patient changed one battery and alarms then stopped. The coordinator told the patient to change the second battery, no alarms occurred again. The patient was encouraged to change the batteries to the power base unit (PBU). Again, there were no alarms and the self test was ok. The patient came to the clinic four days later to pick up new batteries for her left ventricular assist device (LVAD); the old batteries where given to Bio-Med. The manufacturer Thoratec told us, "As part of our efforts to continuously improve the quality and reliability of HeartMate batteries we have implemented an improved screening process at our battery supplier, which has three essential features: A simple cycle process that the supplier has run all along, which involves running each battery twice through a charge/discharge cycle at loads representative of end-use; a rapid, partial cycle course at relatively high current specifically designed for high sensitivity to 'bad' cells and/or poor workmanship; improved metrics and acceptance limits based on our experience and understanding (e.g. 'negative voltage change (dV)', end-of-charge current, etc.), some of which are similar in some ways to the way in which [you] characterize batteries at your institution. Since we introduced HeartMate batteries from the improved screening process late last year we have not confirmed any reduced support time issues with these batteries to date".
Thoratec/HeartMate II Lot # MG264 Patient brought 2 batteries into clinic; stated that the batteries would not hold a charge. The 2 batteries involved in this incident were exchanged with the new HeartMate batteries from the company. The manufacturer Thoratec told us, "As part of our efforts to continuously improve the quality and reliability of HeartMate batteries we have implemented an improved screening process at our battery supplier, which has three essential features: A simple cycle process that the supplier has run all along, which involves running each battery twice through a charge/discharge cycle at loads representative of end-use; a rapid, partial cycle course at relatively high current specifically designed for high sensitivity to 'bad' cells and/or poor workmanship; improved metrics and acceptance limits based on our experience and understanding (e.g. 'negative voltage change (dV)', end-of-charge current, etc.), some of which are similar in some ways to the way in which [you] characterize batteries at your institution. Since we introduced HeartMate batteries from the improved screening process late last year we have not confirmed any reduced support time issues with these batteries to date".
Thoratec/HeartMate II No Device Identifiers In the postoperative period, the patient was noted to have intermittent pump stoppage consistent with a cracked percutaneous lead. The percutaneous lead underwent radiography which demonstrated a potential crack along its distal portion. The patient was taken emergently to the operating room for replacement of the HeartMate II left ventricular assist device.
Thoratec/HeartMate II No Device IdentifiersThe patient was implanted with a HeartMate II LVAD (HMII). Approximately 3 months later at approx. 3 am, the patient was lying on right side and had brushed sand or crumbs off the bed with the eft arm. The patient "felt like something dropped or pulled" on her side. The pain radiated to arm and chest. The patient took an ultram and norco and later took two nitroglycerin at 5 minute intervals. The pain was "like soreness in the chest and stomach". The patient became dizzy when moving from the bed to retrieve the HMII pump parameters manual. The patient also experienced nausea with dry heaving and a headache. A family member called EMS. The patient was transported to the ER. In the ER, the patient was evaluated with CT head, CXR, TTE, labs and was brought to CVICU for further management for possible acute LVAD hematoma. A CT scan demonstrated a large anterior mediastinal hematoma with compression of the right ventricle. Contrast enhancement demonstrated extravasation of blood into the hematoma along the outflow graft. The patient was taken to the operating room the day after the event. It was evident that the outflow graft connector had become disengaged from the outflow end of the HeartMate II pump. Outflow cannula was reconnected to HeartMate II pump. The patient is currently recovering in ICU.
Thoratec/HeartMate II Model 103593 The patient called with complaints of not getting enough time from the batteries for the LVAD. The patient was only getting approx. 45-60 min from a set of batteries. The patient was told to come to the clinic in CVC for loaner batteries and to have Biomedical look at the current batteries. The patient came in and was given loaner batteries. The patient was still having the same problem with the loaner batteries. Both set of batteries were tested and found to be in good condition. The decision was made to also change out the patient's primary controller to the back up and to give the patient a new back up controller. The procedure was done and the patient tolerated the procedure well. The new controller is working properly. Of note, we have had two other patients who have experienced similar problems. WE contacted the service rep and the rep acknowledged that they have been having problems like this with this controller.
Thoratec/HeartMate II Model 103593The patient paged the VAD Coordinator to report that the controller had been changed out at home at 11 pm. The patient reports changing over to PBU from batteries and then hearing a steady solid tone. All the lights on the controller were going off and the black power cable on the controller "lit up and burned a hole through the gray cable". The patient was on batteries when the coordinator returned the call. The coordinator walked the patient through transferring over to the PBU without problem. The patient did a self test on the controller, and had four green power lights on the controller. The patient was instructed to come in first thing in morning to get a new back up controller and return the malfunctioning one to us. The patient was also instructed to page us if he had any further problems or concerns.
Thoratec/Stroke Volume Limiter No Device IdentifiersThe Stroke Volume Limiter (SVL) on the patient was not filling completely. A vent of the SVL occurred and the patient “felt funny but was still awake.” Five minutes later, a check of the stroke volume limiter was done and it was not completely filling. A second venting of the SVL occurred and the patient then passed out. The SVL and console were changed out. The new SVL and console were vented and were completely filling and emptying. The patient sustained cerebral hypoxia and never fully recovered purposeful movement of all extremities. The patient remained on respiratory ventilatory support.
Thoratec/HeartMate II Model 103593The patient paged the VAD Coordinator and reported that when changing over to PBU from batteries they heard a steady solid tone and all the lights on the controller went off. Aditionally, the black power cable on the controller got hot. Just before calling the coordinator the patient changed back to batteries. With the VAD Coordinator on the phone, the patient transferred again to the PBU. This time the controller gave the backup controller alarm and the display read "change out controller.” Thoratec support was called by the coordinator out of concern for the percutaneous line (driveline). The patient was told to come in for controller change out and to bring in all the equipment. The waveform and data logger were sent to Thoratec for evaluation on both controllers. The patient was monitored in the clinic for two hours before being allowed to go home. From the waveform analysis, Thoratec felt that the controller change out and replacing the patient power line had solved the problem.
Thoratec/HeartMate No Device IdentifiersA patient with an ICD had a VAD implanted as bridge to transplant. After surgery, the MD was unable to interrogate the ICD. The next day, the tech was also unable to interrogate the ICD. One week later, the company rep attempted to interrogate and was also unsuccessful. This was followed by the VAD coordinator, company rep and techs repeated attempts to interrogate. The problem was determined to be that interaction between the VAD and ICD prevented the ICD from being turned on. This is a known interaction between the programmer and St. Jude ICD in conjunction with HeartMate II due to use of the same frequency. Since there was no work-around for the telemetry problem, the ICD remains in the patient, off, and unable to be interrogated. The patient is stable at this time.
Thoratec/LVAD Console No Device IdentifiersDuring implantation, there was a pop and then an electrical smell from the Thoratec DDC/VAD. The VAD alarmed "battery.” The patient flow was never disrupted. The backup VAD was readily available, was set up, and the devices were switched.
Thoratec/HeartMate II Lot # 71217The pump failed, but it was not able to be evaluated while in the patient. All cables were checked, with no evidence of failure. The patient was unable to withstand surgery to remove the device. We suspect either cable failure or that the patient developed a clot which caused the device to fail. The manufacturer would like the device so they can evaluate it. We have the device sequestered at this time.
Cardiac Assist, Inc/TandemHeart No Device IdentifiersThe patient was admitted from an outside hospital in cardiogenic shock, status post (s/p) MI to the catheterization laboratory. Stents were placed, and an IABP and Tandem ventricular assist device (VAD) were placed. About 18 hrs after VAD was placed, the IABP abruptly alarmed and stopped. The patient was already on pressors. The RN observed that the console wouldn’t run. The console was switched to back-up, and multiple attempts to restart were unsuccessful. There were expert clinicians at the bedside. The company was contacted for assistance to troubleshoot. The patient became less stable, requiring increased vasopressors. When the VAD could not be restarted within 15 minutes by troubleshooting at the bedside, the patient was rebolused with heparin. The VAD was clamped and the device was decannulated and removed. Subsequently the patient remained on a ventilator, IABP, and pressor support. The patient was stabilized over several days and was eventually weaned from support. The patient eventually was discharged 14 days later to rehabilitation with no neurovascular sequelae. After analysis of failed device by manufacturer (Cardiac Assist) we were instructed that if any high flow readings are seen in the Cath Lab on insertion, this should prompt immediate swap out of the VAD device.
ABIOMED, Inc./ BVS 5000 Bi-ventricular Support System Catalog # 0505-0032-MHThe patient was on an LVAD (left ventricular assist device) when blood started spurting out of a hole in the tubing.
Berlin Heart, Inc./ EXCOR Pediatric Model P25P-001A pediatric patient was admitted last year with cardiogenic shock secondary to an idiopathic dilated cardiomyopathy, likely due to viral etiology. The child was immediately cannulated for extracorporeal membrane oxygenation (ECMO) support. The child was eventually weaned off ECMO, but was then required to be placed back due to poor cardiac output. The child underwent implantation of a Berlin Heart left ventricular assist device approximately one month after admission. Despite optimal anticoagulation, the child has developed enlarging thrombus primarily on the outflow valve of the pump. A decision was made to proceed with a pump exchange three months after implantation. The Berlin Heart left ventricular assist device pump was changed two months later, after the pump developed increasing thrombus formation despite optimal anticoagulation. The pump had accumulating thrombus primarily in the outflow valve. The pump was exchanged again one year post-implantation. Two months later, the pump developed a crack in the extracorporeal portion of the apical cannula. This was controlled with digital pressure while the child was emergently resuscitated. The child was then taken emergently to the operating room for a pump change. A crack developed in the assist device tubing, which led to bleeding and probable CNS (air) insult leading to collapse. The child also had down time of about five minutes in the OR during pump change. The child has been hemodynamically stabilized on the ventilator but has been cooled and CNS status is unknown. Initial EEG tracing diffuse showing no seizure, but CT suggests right middle and posterior ischemic event with loss of white/gray differentiation. The child has been waiting for a transplant ever since. After a long discussion with the family, their wish was to withdraw further support, and to make the child’s organs available for donation. Hospital has the device sequestered. Manufacturer is awaiting return of the device for investigation.
Cardiac Assist, Inc./TandemHeart Model EC-1000Fluid was leaking from the housing of the Tandem Heart.


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Updated April 1, 2009

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