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U.S. Department of Health and Human Services

MedSun: Newsletter #26, July 2008

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Newsletter #26, July 2008


How Human Factors Lead to Medical Device Adverse Events

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By Suzanne Rich, RN, CT, MA
FDA Medical Device Safety Website

Human factors is the science that focuses on understanding and supporting how people interact with technology. To minimize human factors problems, devices should be designed according to users' needs, abilities, limitations, and work environments. This includes the design of the device's user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device…

Additional Information:

How Human Factors Lead to Medical Device Adverse Events. Rich, Suzanne; RN, CT, MA. FDA Medical Device Safety Website. June 9, 2008.

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FDA's Sentinel Initiative

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FDA Website
On May 22, 2008, FDA launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System--a national, integrated, electronic system for monitoring medical product safety. The Sentinel System will enable FDA to query multiple, existing data sources, such as electronic health record systems and medical claims databases, for information about medical products. The system will enable FDA to query data sources at remote locations, consistent with strong privacy and security safeguards…

Additional Information:

FDA’s Sentinel Initiative. FDA Website.

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Request for Proposals: Research in Patient Safety

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National Patient Safety Foundation

NPSF Call for Letters of Intent to Conduct Research and Development in Patient Safety
Applications invited for grant projects beginning 2009

The National Patient Safety Foundation's (NPSF) Research Grants Program seeks to stimulate new, innovative projects directed toward enhancing patient safety in the United States. The Program's objective is to promote studies leading to the prevention of human errors, system errors, patient injuries and the consequences of such adverse events in the health care setting. In this first stage of a two-stage application process, Letters of Intent (LOIs) are solicited for research and development that is broadly related to identifying the causes of preventable injuries and errors and/or developing prevention strategies and methods to implement them. From these LOIs, a subset will be selected for preparation of a final proposal.

An original hard copy AND a CD-ROM with the full LOI document must be received by NPSF no later than July 23, 2008. The number of grants to be awarded will depend on the nature and quality of applications received and the total funds available. A multidisciplinary team of experts will evaluate the LOIs. Investigators will be notified of the status of their LOIs no later than September 25, 2008.

In the second stage of the process, a limited number of applicants will be invited to submit a full proposal, for which more detailed instructions will be provided. Full proposals will be due on December 8, 2008. Grant recipients will be notified no later than February 20, 2009.

Please send your original copy AND CD-ROM of the Letter of Intent to:

Anita Spielman, Program Manager
National Patient Safety Foundation
132 MASS MoCA Way
North Adams MA 01247

For more information:

Additional Information:

Request for Proposals: Research in Patient Safety. National Patient Safety Foundation.

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Mismatching Medical Devices and Accessories

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Pennsylvania Patient Safety Authority
PA-PSRS Patient Safety Advisory

We are posting this information because we continue to see reports describing injuries to patients from the use of incompatible device parts. The article entitled, "Mismatching Medical Devices & Accessories," from the Pennsylvania Patient Safety Authority describes device issues with the Gomco circumcision clamp, which the FDA has issued a Public Health Notification in 2000 online available (see Additional Information below). This article also describes patient injury when a Padgett blade was inserted into a Zimmer dermatome device. We continue to see reports of this nature. You may read a recent MedSun report online available (see Additional Information below).

Additional Information:

Mismatching Medical Devices and Accessories. Pennsylvania Patient Safety Authority. PA-PSRS Patient Safety Advisory. March 2005, Volume 2, Issue 1.


Potential for Injury from Circumcision Clamps. FDA Public Health Notification. August 2000.

MedSun Report

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Lead-Associated Endocarditis: the Important Role of Methicillin-Resistant Staphylococcus Aureus

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BACKGROUND: Infection is a potentially life-threatening complication of cardiac device implantation. Lead-associated endocarditis (LAE) may be the most serious complication since it is associated with a high mortality. METHODS: The medical records of patients referred to our institution for the treatment of LAE between 1999 and 2007 were reviewed. RESULTS: A total of 51 of 107 patients referred for device-related infections met the criteria for LAE. Of these, 19 occurred within 6 months of their most recent procedure (early), while the remaining 32 occurred more than 6 months later (mean = 31.9 months post procedure). Devices included pacemakers in 33 patients and ICDs in 18 patients. The most common organism responsible for infection was Staphylococcus aureus (S. aureus) followed by coagulase-negative staphylocci (22%) and streptococci (12%). Methicillin-resistant S. aureus (MRSA) accounted for 67% of the S. aureus infections. Coagulase-negative staphylococci were responsible for only 26% of early and 19% of late cases. A distant site of infection was common (26/51 = 51%), particularly in patients with MRSA LAE. The device and leads were removed percutaneously in all patients. Only one patient failed to respond to intravenous antibiotics. CONCLUSIONS: Our data suggest that methicillin-resistant S. aureus is an important pathogen in LAE. Since many infections occur months after the last device procedure, hematogenous spread of organisms from a distant site may be an important contributing factor. These data suggest that strategies to prevent hematogenous infection, particularly with S. aureus, are critical in patients with implantable cardiac devices.

Additional Information:

Lead-Associated Endocarditis: the Important Role of Methicillin-Resistant Staphylococcus Aureus. Greenspon, AJ; et al. Journal of Pacing and Clinical Electrophysiology. Division of Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA

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ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines

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**in process

Additional Information:

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Epstein, AE; et al. May 2008.

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Pacemaker and ICD leads: Strategies for Long-Term Management

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Pacemaker and defibrillator therapy is on the rise as a result of expanding indications. Unfortunately, this trend is associated with an increased number of cardiac device-related complications. Lead failure, device infection and vascular complication are not uncommon and may cause significant patient morbidity and mortality. Furthermore, the considerable variability in the approach to dealing with device-related complications not infrequently leads to additional problems and complications. This review is intended to provide general guidelines and strategies for long-term management of cardiac devices. Proper implantation techniques that focus on primary prevention of complications, as well as, planning for future procedures are essential. The use of sterile techniques and implementation of peri-operative antibiotics are well supported in clinical trials. Additionally, minimizing the amount of implanted hardware and limiting the procedure length have also been shown to decrease the rates of infectious complications. Once device infection is confirmed, the primary objective, short of a few exceptions, should consist of the entire system removal via open surgery or percutaneously and antibiotic therapy before reimplantation. Vascular occlusions are not uncommon; however, in the majority of cases they are asymptomatic. Nonetheless, they pose a significant problem with device reimplantation, especially in the younger patients who will require multiple generator exchanges in the future. Site preservation should, therefore, become the primary objective. This can also be accomplished with the open surgical or percutaneous device removal. The latter is very safe and effective when performed in experienced centers. Finally, lead follow-up must be routinely conducted to identify problematic leads, prevent further reimplantations, and guide future research.

Additional Information:

Pacemaker and ICD leads: Strategies for Long-Term Management. Wilkoff, BL; Borek, PP. April 2008.

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Recently Recalled Devices

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To view recently recalled devices, please visit the website listed under Additional Information below.

Additional Information:

Recently Recalled Devices

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Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)

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FDA MedWatch Safety Alert
FDA is investigating the possible association between the use of medicines known as tumor necrosis factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. These individuals were treated with TNF blockers for Juvenile Idiopathic Arthritis (JIA), Crohn’s disease or other diseases. FDA will communicate the conclusions and any resulting recommendations to the public after it completes its evaluation of the new information within about six months…

Additional Information:

FDA MedWatch Safety Alert. Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia). June 4, 2008.

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Point-of-Care Testing

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Lynn Henley, M.S., M.B.A., Patient Safety Staff, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration


It is no secret to laboratorians that laboratory testing has changed considerably during the last twenty years. This shift is occurring in the hospital, in the physician office, and in the home. While many things have contributed to this shift, the purpose of this paper is to provide a broad overview of one segment of laboratory medicine – that is, point-of-care testing (POCT).

POCT is commonly defined as laboratory diagnostic testing performed at or near the site where clinical care is delivered. This testing is performed by using medical devices such as blood glucose monitors, critical care analyzers, urinalysis instruments, etc. Nearly one third of the entire in vitro diagnostic testing market is now comprised of POCT. Steven Gutman, M.D., M.B.A., Director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety notes that “the laboratory medicine industry is dazzling, the technology is there, and the ability to create portable tests providing robust results at the point of care has never been greater.” (S. Gutman, personal communication, April 28, 2008) As a result the market for POCT is predicted to grow at a 9% rate compounded annually so that it is projected to be $10 billion in 2010.2 This paper will provide a basic high-level overview of hospital POCT. It is the first in a series of three on the subject; the second and third papers will discuss an analysis of the types of reported POCT problems to FDA and future directions, respectively.


Within the last century, laboratory science has evolved tremendously as a result of improvements in testing technology, increased knowledge of disease processes, and advances in methods for establishing and evaluating test performance. Over time, laboratory testing has moved from the hospital lab, to satellite laboratories, and has now branched out to include POCT at the patient bedside in the hospital and, in some cases, for example glucose or prothrombin time testing, in the patient’s home. During the past twenty years, new technology and regulatory requirements have permitted the creation and wide adoption of POCT. 3 Advances in microchemistry (such as biosensors and whole-blood analysis), microcomputerization, miniaturization, and noninvasive testing procedures represent the technological changes resulting in smaller, handheld devices. This has led to the increase in the use of diagnostic medical devices occurring throughout the hospital.4

Changes in regulatory requirements have also contributed to the transfer of diagnostic testing from the laboratory to the bedside. The Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) established minimum quality standards for all laboratory testing sites in the United States. CLIA ’88 allowed for a separate category of simple testing called “waived” testing. Waived tests were exempt from standard CLIA quality control and quality assurance requirements.5 CLIA waived tests were described as examinations or procedures that “are cleared by the United States Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, or pose no reasonable risk or harm to the patient if the test if performed incorrectly.”6 The waived tests at the time included such simple tests as urine dipsticks, urine pregnancy testing, and spun hematocrits. When the regulations were developed, the extent of point-of-care testing was not completely foreseen. Waived tests now comprise an increasing number of point-of-care testing diagnostics.7

Under the current process, a waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use.7 Tests in category 1 are automatically waived without review; tests in category 3 require careful review to assure the product is appropriate for over the counter use; tests in category 4 require careful review to assure they meet statutory CLIA requirements for waiver. Earlier this year, FDA published final guidance outlining the type of information needed to assure a product could be waived.

Benefits of POCT

The advancement of POCT in hospitals has been advantageous to patients and to the clinical community. Hospital-based POCT is beneficial because it rapidly delivers results to the medical practitioner and enables faster consultation with the patient, enabling the practitioner to begin treatment sooner. Because patients are usually treated more quickly, costly hospital stays may be reduced. Faster patient treatment may, in turn, lead to improved patient outcomes.6 One example is the use of handheld blood analyzers, which permit rapid analysis of blood gases in the critical care unit. For the critically ill patients in this unit, results received in such a manner can make treatment faster and survival more likely. In addition, patients may need to spend less time in the hospital if diagnosis is more rapid. Early diagnosis directly addresses one of the primary challenges of modern healthcare, which is improving the quality and accessibility of care while reducing costs.

Another benefit of POCT is that a smaller specimen may be needed than that needed for traditional laboratory testing.8 A few drops of blood or less can provide accurate results within a few minutes. This permits the use of fingersticks.1 The fact that only a few drops of blood are needed versus a larger quantity may, for very ill or frail patient may lessen the need for blood transfusions. In addition, the specimen does not need to be transported. This may reduce preanalytic errors such as confusion between samples from several patients, as the specimen is usually handled by one person for one patient at the bedside.6 Furthermore, this benefit reduces the need for, and cost involved with, phlebotomy and other types of invasive sample retrieval. Many analytes are available for this type of testing, including blood gases, electrolytes, pregnancy, cardiac, and infectious disease testing (see Appendix 1).

These benefits are possible only with proper communication between laboratorians, physicians, other medical staff, and patients. The individual who reads or interprets POCT results must communicate the results in a timely fashion to the appropriate healthcare provider. Standard operating procedures must be in place so that the nurse reading the analysis at the bedside conveys the information to the appropriate department or healthcare provider. As POCT becomes more entrenched in modern healthcare, establishing procedures involving this communication will be critical.

Problems with POCT

Although there are many positive factors associated with the implementation of POCT, challenges remain with this type of testing. As in standard laboratory testing, patient safety problems arise in the preanalytic, analytic, and postanalytic processes with POCT. The greatest area of concern for laboratory testing in general resides in preanalytic and postanalytic phases of the testing process. However, with POCT the analytic phase is also important because operators often have little laboratory experience and minimum analytic skills.9 Problems include lack of proper testing environmental controls; failure to follow the correct test procedures; failures in instruments, reagents, or software; and failure to follow proper quality control procedures.10

Table 1. A Representative Taxonomy of POCT Laboratory Errors in Use by a Number of Laboratories with Minor Modifications.11

Check ALL that apply:

Preanalytic error

___ Requisition incorrect/incomplete or failure of care provider to order the correct test

___ Incorrect specimen container (e.g., blood tube) or order of draw problem

___ No specimen collected or received

___ Primary specimen tube not labeled

___ Primary specimen tube mislabeled

___ Suboptimal/ruined specimen because specimen clotted

___ Suboptimal specimen because quantity not sufficient

___ Suboptimal specimen because of fluid contamination

___ Specimen suboptimal, ruined, or inadequate for other reason

___ Data entry error when logging in a specimen

___ Other preanalytic error

Analytic error

___ Human error

___ Instrument error

___ Reagent error

___ Other analytic error

Postanalytic error

___ Critical (panic) results not called

___ Critical (panic) results: unable to contact provider

___ Postanalytic delay in reporting

___ Results reported to wrong provider

___ Incorrect results reported because of postanalytic data entry error

___ Incorrect results reported for other reasons

___ Failure of care provider to retrieve result

___ Misinterpretation of laboratory result by care provider

___ Other postanalytic error

Quality assurance can be maintained by strict adherence to procedure and attention to uncontrolled reagents and equipment.12 Much of the responsibility of standardization rests with the laboratory director on the CLIA certificate. A POCT committee consisting of the laboratory director as well as healthcare practitioners from varied disciplines can assist an institution in developing procedures and monitoring those procedures for improvement. Just as documentation from multiple sites, operators, and devices needs to be coordinated, representatives from different parts of the hospital need to work together to supervise the information flow. This committee can also ensure that contamination occurs infrequently and that reagents are stored properly.1

Operator error accounts for a large number of problems. As operators have changed from laboratorians to hospital bedside caretakers and patients, chances for error have increased. According a recent survey (2002) performed by the Centers for Medicare and Medicaid Services (CMS) on the subject of point-of-care testing, sources of medical error with POCT are routinely due to operator error. CMS observers examined test performance in 436 laboratories in eight states and found that 19% of testing personnel were neither trained nor evaluated in the performance of the assays. Furthermore, 32% of the test operators could not locate test instructions when asked. Challenges presented by the increased use of POCT may be improved by supervision of test operators’ performance, assessment of their competence, and demonstration of their proficiency.13 As new technologies permit the increased automation of these medical devices, the potential for operator error may decrease.1 Automation may also help with more accurate data entry as results of POCT are transferred to patient charts and other databases.

In addition to operator error, medical device failures include malfunctions, manufacturing defects in design or development, or material problems such as product instability. 14 Malfunctions are typically evidenced by inaccurate test results. Dr. Gutman reported in 2007 that glucose meters and test strips represent the largest category of IVD products generating the highest volume of patient death-and-injury reports. He said that glucose meters top the list because of the extraordinary volume of their use, their use under environmentally diverse conditions, and the risks associated with inaccurate test results. 15 Gutman also noted, “The tension between increased access to test results and potential degradation of the quality of results is a particular challenge to both regulators and users. Fortunately, professional groups are beginning to pay attention to this challenge and to apply evidence-based technology assessment to this important product line.” (S. Gutman, personal communication, April 28, 2008) A follow-up article on adverse events reported to FDA will appear in an upcoming MedSun newsletter to more fully characterize these types of problems.

New Directions

Technological advances in POCT include miniaturized devices and wireless communication. Changes such as these will alter the manner in which doctors care for patients and patients will take on increased involvement in their own care. Electronic medical records will become an important part of POCT. Medical devices used for testing in this manner will be able to accommodate the new age of personalized medicine. A further discussion of new directions in POCT will occur in a forthcoming article.


POCT offers more rapid diagnosis and may offer more successful outcomes16 for the patient. Challenges for the healthcare community and the patient remain as this type of testing becomes more commonplace and as new technologies are developed. However, development of quality assurance programs can ensure that modern healthcare extracts the most benefit from these devices to improve patient outcome.

Appendix 1. A Listing of Some Types of Point-of-Care Testing Currently in Use.
Diabetes testing
--Hemoglobin A1c
Reproductive testing
--Human chorionic gonadotropin (pregnancy)
--Luteinizing hormone and Fern Test (ovulation)
--Follicle-stimulating hormone (menopause)
Renal function
--Urine dipstick
Infectious disease
--Helicobacter pylori
--Influenza A and B
--Respiratory syncytial virus
--pH and amines (bacterial vaginosis)
Occult blood
Drugs of abuse testing
Therapeutic drug monitoring
--High-density lipoprotein
--Low-density lipoprotein
Cardiac Markers
--Brain natriuretic peptide (BNP, NT-proBNP)
Liver function
--Aspartate aminotransferase (AST)
--Alanine aminotransferase (ALT)
Coagulation (prothrombin time/international normalized ratio)
Tumor markers (bladder tumor-associated antigen)

Nichols, J. (2007). Point of care testing. Clinics in Laboratory Medicine. 27(4), 893-908.
Cambridge Consultants. (2006) Point-of-Care: the demise of high-throughput screening? Diagnostics Report, Cambridge, UK.
3U.S. Department of Health and Human Services, National Institutes of Health. Point-of-Care Diagnostic Testing Fact Sheet. July 2007.
4 Kost, G., Ehrmeyer, S., Chernow, B., Winkelman, J., Zaloga, G., Dellinger, P., & Shirey, T. (1999) The Laboratory-Clinical Interface Point-of-Care Testing. Chest. 115 (4), 1140-1154.
5U.S. Department of Health and Human Services, Health Care Finance Administration. Clinical laboratory improvement amendments of 1988, final rule. Federal Register 1992, 7001-288.
6Commission on Laboratory Accreditation. Laboratory Accreditation Program Point-of-Care Testing Checklist, College of American Pathologists, October 31, 2006.
7U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Devices and Radiological Health, CLIA Clinical Laboratory Improvement Amendments. Retrieved May 19, 2008, from http://www.fda.gov/cdrh/clia/
8 Salem, M., Chernow, B., Burke, R., Stacey, J., Slogoff, M., & Sood, S. (1991) Bedside diagnostic blood testing: Its accuracy, rapidity, and utility in blood conservation. Journal of the American Medical Association, 266, 382-389.
9Westgard, J. & Westgard, S. (2006) The Quality of Laboratory Testing Today. American Journal of Clinical Pathology. 125(3), 343-54.
10 Jones, B., and Meier, F. (2004) Patient safety in point-of-care testing. Clinics in Laboratory Medicine. 24(4), 997-1022.
11Astion, M. (2006). Right Patient, Wrong Sample. U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, Morbidity & Mortality Rounds on the Web, Case & Commentary, December 2006. Retrieved May 19, 2008 from http://webmm.ahrq.gov/case.aspx?caseID=142#ref2
12Meier, FA, & Jones, BA. (2005) Point-of-Care Testing Error: Sources and Amplifiers, Taxonomy, Prevention Strategies, and Detection Monitors. Archives of Pathology and Laboratory Medicine, 129(10), 1262-1267.
13Price, C. & Kricka, L. (2007) Improving Healthcare Accessibility through Point-of-Care Technologies. Clinical Chemistry, 53, 1665-1675.
14Beyea, S. (2008) Addressing problems with medical devices – Patient Safety First. AORN Journal.
15Gutman, SI. (2007, May) Top-Ten Reported In Vitro Diagnostic Devices. MedSun Medical Products Safety Newsletter, 14. Retrieved May 19, 2008, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=14
16Kazmierczak, S., Bleile, D., Aron, K., Mansour, M., & Kazmierczak, M. (2007, November) POCT Assessment: Implementing new instrumentation helped improve turnaround times and performance at the Oregon Heath and Science University in Portland. Advance Newsmagazine for Medical Laboratory Professionals, 1-4.

Acknowledgments are made to the following people: Ann Chappie, M.T.; Ruth A. Chesler, M.T.; Donna Engleman, R.N.; Marilyn Flack; Steven Gutman, M.D., M.B.A.; and Jill Marion, B.S.E.

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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 April 1 through April 30. 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.


Device: Syringe, Contrast Injector; Optiray
Lot# P080A
Manufacturer: Covidien Mallinckrodt

Device: Injector, Contrast; Liebel Farshein Injector
Model # 90330 d
Manufacturer: Covidien Mallinckrodt

Problem: While performing IV angiogram the power syringe cracked down the side. The injector settings were: 25 ml/20ml/sec and 249 psi were reached according to the injection archive. The injector was set to max out out at 1000 psi. The injector did not reach the maximum output. We have had multiple incidents with these syringes on several different injectors. This injector was service by the company 6 days after the event and was found to be working properly within specifications.


Device: Pacemaker, External Temporary
Model# 5388
Manufacturer: Medtronic Inc.
Problem: A post cardiac surgical patient was pacer dependent in the surgical intensive care unit several hours after completion of surgery, when the physiologic monitoring alerted clinical staff to the fact that the patient was asystolic. Immediate examination of the patient found the temporary external pacer to be completely turned off. CPR was performed while another pacer could be found. Upon connection with the replacement pacer the patient was returned to the expected rhythm. It is known that there was no indication of a low battery three hours prior to the incident and the 9 volt battery that was in use when the incident occurred was found to be within normal charge limits, at 8.75 volts, after the incident. Since the patient was totally pacer dependent and not active, and no one else was in proximity of patient when the event occurred, it appears the unexplained power off of the pacer caused the adverse event. Manufacturer indicated intent to examine and test the pacer as well as battery.

Device: Module, Physiological Monitor, NIBP; Datex Ohmeda M-PRETN-01 Measurement Module
Model# M-PRETN-01
Manufacturer: GE Medical Systems Information Technologies
Problem: During preoperative anesthesia machine checks, the doctor noted a NIBP "cuff occlusion" error message on machine S5 monitor display. The M-PRETN multiparameter vital signs module would not allow noninvasive blood pressure measurement. The doctor checked all cables and cuff tubing for kinking, and there was none. This error has been reoccurring on several of these modules and has required repair by the manufacturer. In every case the manufacturer has replaced the NIBP interface PCB to correct error. The problem with the remaining modules keeps occurring, which causes delay and or cancellation of surgical procedures. The manufacturer has been notified of these failures, but has not resolved this ongoing issue. This current report is for two additional module failures.

Device: Cooling/Warming Blanket; Maxi-Therm Lite
Model# 876
Lot# 8346
Manufacturer: Cincinnati Sub-Zero Products Inc.

Device: Hypo/hyperthermia Unit; Blanketrol II
Model# 222
Manufacturer: Cincinnati Sub-Zero Products Inc.

Problem: Patient was on cooling blanket. The blanket sprang a leak, soaking the bed and the patient. The leak occurred near the location where the 2 tubes mate with the blanket surface.

Device: Monitor, Physiological; Dash 3000
Manufacturer: GE Medical Systems Information Technologies
Problem: Monitor alarmed. Nurse pressed silence button on monitor and monitor went blank. She turned monitor back on. A while later monitor alarmed again. Again, nurse pressed silence and monitor went blank. Logs were downloaded and sent to GE.


Device: Pump, PCA; LIFECARE PCA 3
Manufacturer: Hospira Inc.
Problem: Even though the PCA pump was plugged in, the battery light still remained on. Once the alarm went off, the battery light would not turn off. The PCA pump was replaced for another one. Biomedical engineering determined that a faulty power supply was the source of the problem.

Device: Catheter, Pleural Drainage; Pleurx Pleural Catheter
Lot# L79256
Catalog# 50-7000
Manufacturer: Cardinal Health
Problem: A Cardinal Pleurx catheter was placed for the drainage of pleural fluid. About two weeks later, the catheter was removed because there was leaking around the catheter site and the catheter had become dislodged. It was subsequently determined that there have been 10 other patients that have had Pleurx catheters placed at our facility during a three month period of time that have had complications that include leakage around the catheter site, infection at the catheter site, or the catheter becoming dislodged. Clinicians involved have expressed that the complications described above may be related to catheters not adhering to the skin as they were designed to do. Also, information provided to us by the manufacturer (Cardinal Health) indicates that excessive amounts of glue used during the manufacturing process allowed the adhesive to come in contact with the cuff material.

Device: Phototherapy System, Infant; Wallaby 3 Photo Therapy Unit
Manufacturer: Respironics, Inc.
Problem: Parents report that they were awakened by a shattering noise, "a huge bang" "like a window shattering." The parents went to the room where their infants were and observed glass on the floor (the infants were receiving phototherapy). The yellow light on Wallaby unit was flashing and the green light was on. The unit appeared to be operating correctly and the second bulb had turned on automatically and phototherapy was being delivered. The parents reported unplugging the unit and cleaning up the glass. No report of injury. The unit was plugged back in to continue therapy. The parents called the hospital to provide notification of the event. The home was visited by a staff member. The involved wallaby unit was recovered and returned to the manufacturer for evaluation. Manufacturer response for Phototherapy, system, infant, Wallaby 3 Photo Therapy Unit: Per a report forwarded from the company – Unable to confirm complaint of ‘bulb exploded.’ There is no evidence, shards, or parts internal of unit. However there is a bulb enclosure installed with a missing element. Unit also appears to have been dropped. The front panel enclosure is cracked/marred/damaged. The outer metal enclosure is dented on the left rear corner. Replaced bulbs with known good bulbs and ran for 24 hours total (switching both). No operational issues were found/noted. QA will hang onto and archive the suspect bulb for a period of one year. Unit is serviceable and will be returned in service for repair after investigation completed and unit released.

Device: Tray, Sterilization; FlashPak
Catalog# 9020
Manufacturer: Symmetry Medical

Device: Indicator, Sterilization Process; Comply Steri Gage
Model# Class 5
Lot# 201301SP
Catalog# 1243
Manufacturer: 3M

Problem: When items are placed within these pans to flash sterilize, the indicators do not change color to indicate that the sterilization process has taken place.

Device: Tubing, IV, Infusion Set; MiniLoc
Model# 0632010
Manufacturer: Bard Access Systems
Problem: The nurse received a phone call from the patient's mother stating that the patient had pulled their Bard MiniLoc Safety Infusion IV Set out. The nurse went to the room immediately and noticed Huber needle line was broken at the connector site. The nurse de-accessed and re-accessed immediately and obtained a positive blood return and flush. There were no further complications. Clinical Engineering examined the device and it appeared that the tubing came unglued from the luer lock portion. There was no evidence of a crack or break in the tubing. The Bard MiniLoc Huber needles have been having many issues hospital-wide with the tubing detaching from the luer lock portion of the device Bard has been slow to respond, but are now addressing the issue. In response to this issue, Bard informed us that they changed the glue process approximately 4-6 weeks ago, and will replace our old lots with new ones. We are currently trialing new products to replace this device, and have issued a notice to all users to warn them of the continuing issue.


Device: Analyzer, Blood Gas; ABL 835 Flex
Model# 835
Manufacturer: Radiometer America, Inc.
Problem: Lab technician was processing six inpatient blood gas samples and noticed that all samples had resulted with low readings. Delta checks for equipment were within normal range. Results were communicated to providers. Five of the six patients had treatment plans changed because of the low readings. It was then discovered by lab personnel that there was a clot in the blood gas machine, and that the results that had been processed were incorrect. Providers were notified and appropriate changes were made.


Device: Electrode, ESU, Suction Coagulator; LectroVac
Model# E2610-6
Lot# 125150
Manufacturer: Covidien Valleylab

Device: Electrode, ESU, Suction Coagulator; LectroVac
Model# E2610-6
Lot# 124355
Manufacturer: Covidien Valleylab

Problem: During a procedure in December 2007, the suction coagulator handpiece being used with the electrosurgical unit became permanently activated. The doctor operating the handpiece was aware that it was active and was able to remove the handpiece without causing harm to the patient. The handpiece was sent to the manufacturer for evaluation. It was found that the foam springs of the hand piece had failed, causing the on/off button to remain permanently activated. On January, 2008, a similar event occurred. Again, the surgeon was able to remove the handpiece without causing harm to the patient. This handpiece has been sent to the manufacturer for evaluation. Results from the manufacturer's evaluation are not yet available. Manufacturer response for ESU suction coagulator hand piece, LectroVac: Failure/misalignment of internal foam springs.

Device: Light Source, Surgical; Stryker X8000
Manufacturer: Stryker Endoscopy
Problem: No injury or incident with any patients. The scrub tech noted that the end of the laparoscope, when connected to the Stryker light source, seemed to become extremely hot very quickly. After cases were completed, we tested the light source and scope with a gown. The light source was set at 90 and turned on with the end of the scope on a gown. We found that this made a hole in the gown in 10 to 15 seconds. We found this alarming, and contacted the manufacturer's representative. The representative came to the hospital, and we demonstrated this to him. He stated that he was aware of issues with the end of the light cord becoming hot, but stated that he was not aware of an issue with the end of the scope also becoming hot. He further stated that the light source should never be set above 50, due to causing increased heat. We tested the same light source, cord, and scope with the unit set at 50 and after 2 minutes there was no hole or damage to the gown. Note that the light sources were set to 90 upon installation and had not been adjusted down since we had no idea that this was an issue or that the unit should not be set above 50 per the rep. We would like manufacturer guidelines on this made available if possible.

Device: Scissors, Surgical; Metzenbaum
Model# 810-01-21218
Lot# 44691
Manufacturer: Tri-anim Health Services, Inc.
Problem: During a laparoscopic total hysterectomy, the insulation on the disposable scissor tip came off. It was retrieved from the patient's abdomen by the surgeon. This is the second occurrence of insulation failure with this particular lot number, and the entire lot is being pulled for return to the manufacturer.


Device: Intraocular Lens, Foldable; TECNIS
Other Device # CE0050
Manufacturer: Advanced Medical Optics, Inc.
Problem: The capsular bag was reinflated with viscoelastic. A foldable
acrylic lens was injected into the capsular bag and was allowed to unfold.
Although there were no visible defects of the intraocular lens, upon examination of the acrylic lens inside the injector, a 2-3 mm area of
the anterior surface of the intraocular lens had presented some opacification and
haziness. To avoid any visual disturbances, this specific intraocular lens was removed.
After removing the intraocular lens, there appeared to be a
possible posterior capsular opening. Therefore, to avoid any possible
extension, viscoelastic material into the ciliary sulcus (Healon) was included.


Device: Lithotriptor; Compact Delta
Model# Fluke 80K-40
Manufacturer: Dornier MedTech America, Inc.
Problem: The machine was turned on and passed the initial check; however, when the patient was positioned on the table; the device would not power up. The case was terminated, and there was no patient harm. The report from the vendor revealed they found a defective pulse transformer, bleed down resister, and also a defective drive power electronic PCB. All issues were repaired, and an overall system operation check was completed. The device was returned to service.

Device: Agent, Bulking, Injectable, for Gastro-Urology Use; Coaptite
Lot# 1007722, 1007300, 1004812
Manufacturer: BioForm Medical
Problem: The physician was unable to inject the bulking agent either because the agent was too thick or the needle was defective. Four boxes of this product were opened and none of them came out of the injectable dispenser.

Device: Catheter, Urinary, Temperature Monitoring; Temperature Management System
Other Device # 402484-00, REV.A, SCT1967
Manufacturer: Phillips Medical Systems

Device: Temperature Management System; Arctic Sun 2000
Manufacturer: Medivance, Inc.

Problem: The Arctic Sun 2000 temperature management system was used as a monitor during therapeutic hypothermia in a patient following an out-of-hospital cardiac arrest. The foley temperature probe, which used for monitoring the patient's temperature, was broken. The end connector piece was found to be missing. There did not seem to be any replacement cables available so the cable was used without the connector. The wires were inserted into the Artic Sun machine, and as a result, the patient's temperature was not accurate. The patient was overcooled to a temp of 29.9 degrees. He became hypotensive but did not have bradycardia or Osborne waves. The therapeutic hypothermia was discontinued and the patient was re-warmed.


Device: Catheter, Suction
Lot# 434501 or 432376
Catalog# 198

Device: Catheter, Suction; Ballard Trach Care "Y" ET ADPTS 6FR 2MM O.D. 12"/30.5CM
Lot# 414362
Catalog# Ref 196

Manufacturer: Kimberly-Clark Corporation
Problem: Intubated patient with an in-line suction catheter. The RCP noted air in the sleeve covering the catheter after suctioning. The in-line catheter was removed and replaced, but the RCP did not notice that the catheter was damaged. Chest X-ray later identified a foreign body in the patient's right mainstem/trachea. The patient underwent a bronchoscopy for removal of a 7 cm tip of suction catheter.

Device: Holder, Endotracheal Tube; AnchorFast
Other Device # 9788
Manufacturer: Hollister, Inc
Problem: Hollister redesigned the ETAD (endotracheal tube attachment device) to the AnchorFast to decrease complications of skin erosion; practitioners believe new design puts patients at higher risk of loss of airway for following reasons: smaller attachment points do not support the device on the face; removal of adhesive tape from upper lip causes the device to fall down on the face; anchor point too far from lip which creates opportunity for tonguing out ET tube; and they are not staying attached near as long as the ETADs were. The company rep. was informed of problems.


Device: Catheter, Ventriculostomy; External Drainage Catheter
Model# believed to be REF INS series catheter
Manufacturer: Integra NeuroSciences
Problem: Prior to MRI, gadolinium contrast material was mistakenly injected by MRI technologist into ventriculostomy external drainage catheter directly into ventricles of brain rather than into nearby IV access catheter. Approximately 17 cc's were injected and about 4 cc's aspirated back after error was recognized. Access port/luer connector on ventriculostomy tubing is reportedly compatible with syringe used for injecting intravenous contrast material. Warning label or coloring of tubing was not readily apparent. IV port taped near ventriculostomy port, causing increased risk for user error.

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Updated July 1, 2008

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