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U.S. Department of Health and Human Services

MedSun: Newsletter #18, November 2007

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Newsletter #18, November 2007

Articles

Issues of Safety in the Use of Magnetic Resonance Imaging

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"New Guidelines on MRI (Magnetic Resonance Imaging) Safety," a July 2007 Patient Safety Network show featured a discussion of serious patient injuries associated with MR procedures. Incidents range from burns from electrodes and cables during MRI examinations to injuries and death from flying metallic objects brought into the MR unit.

Life-threatening and fatal MR-associated accidents are of continuing concern to the radiology community. To help reduce patient risk during MR procedures, the American College of Radiology (ACR) has issued a comprehensive update of ACR Guidance Document for Safe MR Practices, its 2004 white paper on MR safety. The update, Guidance Document for Safe MR Practices: 2007, covers every aspect of MR safety and includes useful information for nonradiology personnel who prepare patients for MR procedures.

Additional Information:

New Guidelines on MRI (Magnetic Resonance Imaging) Safety
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=65#7

Guidance Document for Safe MR Practices: 2007
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/MRSafety/safe_mr07.aspx

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Center for Devices and Radiological Health FY 2006 Annual Report Cites MedSun's Important Role in Postmarket Surveillance

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In its FY 2006 Annual Report, the Center for Devices and Radiological Health (CDRH) cited the MedSun Project as among its key accomplishments that exemplify CDRH's efforts to "advance patient safety by improving problem detection capabilities in marketed device products." MedSun is described as playing "an important role in postmarket surveillance efforts by connecting CDRH to device users." The annual report also notes that CDRH exceeded by 15 percent its 2006 goal of obtaining a 71 percent participation rate from the project’s 350 participating facilities.

Additional Information:

To read more of CDRH’s FY 2006 Annual Report, go to
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm129258.pdf

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AHRQ and the VA Produce Patient Safety Improvement Training DVD Through PSIC

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The Patient Safety Improvement Corps (PSIC), a partnership program between the Agency for Healthcare Research and Quality (AHRQ) and the Department of Veterans Affairs (VA), seeks to improve patient safety by providing knowledge and tools to a range of staff responsible for patient safety reporting, intervention, and analysis in health care facilities and organizations. PSIC recently released the DVD Tools, Methods, and Techniques for Improving Patient Safety, a self-paced, modular approach to training at the institutional level.

The DVD offers downloadable lessons and other resources in eight modules: Patient Safety, Why Bother?; Creating a Culture of Safety; When To Do a Root Cause Analysis; How To Do a Root Cause Analysis; Human Factor Engineering; Management of Risk; Proactive Risk Assessment Tools; and Statistical Tools and Patient Safety Indicators.

The DVD, AHRQ Publication No. 07-0035-DVD, is available from the AHRQ Publications Clearinghouse by calling 800-358-9295 or e-mailing ahrqpubs@ahrq.hhs.gov.

Additional Information:

For more information on PSIC, go to
http://www.ahrq.gov/about/psimpcorps.htm

AHRQ and the VA Produce Patient Safety Improvement Training DVD Through PSIC
http://www.ahrq.gov/qual/psicdvd.htm

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Press Release: Patient Safety Authority Releases Advisory Focusing on Common Causes of Medication Errors

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Drug mix-ups occur frequently due to packaging and sound-alike drug names

HARRISBURG: Medication errors continue to rank high (23%) in the number of reports submitted to the Pennsylvania Patient Safety Reporting System (PA-PSRS). The Patient Safety Authority highlights the common causes of drug errors in its 2007 September Patient Safety Advisory.

Unclear and confusing labeling and packaging as well as look-alike or sound-alike drug names significantly contribute to medication errors, according to data received by the Authority.

"Ambiguous and confusing packaging and labeling contribute to medication errors," said John Clarke, MD, editor of the Patient Safety Advisory.

"Errors can occur because healthcare practitioners become familiar with a certain package's appearance. When the package or label looks similar to that of another product, or is changed, practitioners may not realize the difference.

"Practitioners tend to see what is familiar rather than what is actually there. If a drug has distinctive packaging, the potential for mix-ups may be reduced," added Clarke. "Also, the more prominent parts of the label are not necessarily the ones with the most important information for those dispensing the medication."

Factors that relate to the medication's label or package that contribute to the errors include: problems with readability of labels, confusing expression of the drug's strength or concentration, over reliance on color as an identifier and lack of contrast or visibility for important label statements.

Michael Cohen, R.Ph., M.S., Sc.D., president of the Institute for Safe Medication Practices, a subcontractor with the Patient Safety Authority, said drug packaging errors are nothing new.

"Although more and more pharmaceutical manufacturers take into account how practitioners actually identify and use their products, that has not always been the case," said Cohen. "Therefore, medication errors sometimes occur when a product is misused."

The Advisory also highlights the increased potential for fatal drug errors to occur between two sound-alike generic drug names: morphine and hydromorphone. Hydromorphone is a common alternative to morphine for treating pain if a patient cannot tolerate morphine; however, hydromorphone is much more potent than morphine.

"One of the most common hospital-based sources of medication errors involving confusion over potency is when a patient is improperly switched from morphine to hydromorphone," said Cohen. "Further, analysis of wrong drug errors submitted to PA-PSRS shows that mix-ups between these two medications outnumber all other pairs of medications."

The potency difference in each is as follows: Oral hydromorphone is approximately four times more potent than oral morphine; injectable hydromorphone is approximately seven times more potent than injectable morphine; and injectable hydromorphone is approximately 20 times more potent than oral morphine.

"In seventy-one percent of the reports we received due to mix-ups between morphine and hydromorphone, the errors occurred when these medications were obtained from unit stock prior to administration," said Cohen. "Facilities must be aware of how they are stocking these look-alike and sound-alike drugs."

Cohen added that further analysis of the wrong drug reports involving either morphine or hydromorphone shows that: 36% involve a mix-up between these two drugs; 62% of the wrong drug reports involving both of these drugs show morphine as the prescribed medication and hydromorphone given in error; the most common care areas where this mix-up occurred were medical/surgical units, medical/oncology units, emergency departments, and telemetry units; and 34% of the reports involve elderly patients (patients 65 years and older).

The Patient Safety Advisory outlines strategies for facilities to avoid mix-ups between morphine and hydromorphone, which account for the most common and potentially serious errors that can occur involving two high-alert medications (drugs that carry the risk of significant harm to the patient if used incorrectly).

"The risk exists in almost every healthcare facility in Pennsylvania," said Cohen. "Facilities need to assume that this error will eventually happen in their institution and consider taking the necessary steps while storing and administering the medications to reduce the risk of error and patient harm."

The strategies include: limiting hydromorphone access; reducing the number of different strengths available for each drug; reducing look-alike potential of the drug by using tall man lettering for emphasis on labels; using technology such as bar coding and automated dispensing technology to minimize the risk of error; requiring staff to double check the dose before administering; monitoring patients closely before discharge; educating staff with safety information about potent narcotics through newsletters and in-service meetings; educating patients prior to administering narcotics and repeating the name of the medication out loud to the patient as another source of confirmation.

Cohen said further evidence that facilities need to rethink how they store and administer look-alike and sound-alike drugs comes from the 13,000 reports of wrong drug medication errors collected by PA-PSRS.

"For the first time, we've listed the top twenty-five medication pairs involved with wrong drug errors in Pennsylvania," said Cohen. "I hope facilities take a look at the list and make the appropriate changes in their facilities because many of them look and sound alike which increases the risk for error."

Cohen added that the Joint Commission has established a National Patient Safety Goal (goal 3C) to assure that hospitals address commonly confused name pairs.

Of the 23 percent of all reports that are classified as medication errors, one percent are considered serious events, or events that caused harm to the patient. One in four (25 percent) medication errors involve a high-alert medication.



Additional Information:

September Patient Safety Advisory

http://www.psa.state.pa.us/psa/lib/psa/advisories/sept_2007_advisory_v4_n3.pdf

For more information on the Patient Safety Authority, go to
http://www.psa.state.pa.us

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New Information From FDA/CDRH on Meningitis Risk for Patients With Cochlear Implants

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Two cochlear implant patients, neither of whom was fully vaccinated, recently died from infections. A survey of parents of children with cochlear implants showed nearly half did not know whether their children had received all required vaccinations.

In response to these findings, a reminder of the increased and life-threatening risk of bacterial meningitis in cochlear implant patients and a restatement of the importance of full vaccination were posted by the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) in an “Advice for Patients” article on October 10, 2007.

Cochlear implant patients appear to be at increased risk of bacterial meningitis caused by Streptococcus pneumoniae. Children implanted with cochlear implants with a positioner component are at greatest risk.

Additional Information:

To read the full discussion of this topic, along with background information and recommendations, please go to
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062104.htm

FDA Public Health Notification: Importance of Vaccination in Cochlear Implant Recipients
http://www.fda.gov/cdrh/safety/101007-cochlear.html

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Reporting Tip: Threw Away the Packaging?

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What should you do when you are preparing a [MedSun] Medical Device Report about a problem with a single-use product or device but discover that the packaging of the item has been discarded and can’t be retrieved?

If the original packaging — which includes crucial information to accurately identify the product or device — is not available, please consider the following to obtain the information required to analyze your report.

1. Locate a stock of identical products on the unit or in a nearby supply room.
2. Photocopy the packaging of a like-device to produce an image with the information needed to complete the report —with the possible exception of the actual lot number of the device involved.
3. Attach image to 3500A form. Please make the distinction in your report that it is “sample packaging from like-product.” This copy of the product packaging will be scanned with the report to make exact identification of the product or device more efficient.

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DS-X Device Safety Exchange, a MedSun Program

DS-X Lessons Learned

Question of the Month with Comment

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The September Question of the Month is featured below, along with a recently submitted Comment.

Question:
Findings of a study by J.L. Tri, M.S.E.E.; R.P. Severson, CBET; L.K. Hyberger, M.A., CCRC; and D.L. Hayes, M.D., published in Mayo Clinic Proceedings [82(3):282-285], showed that no problems were found during 300 tests of two different telephone technologies from different carriers. From February through June 2006, the cell or mobile phones were switched on near 192 medical devices in 75 patient rooms. The incidence of clinically important interferences was 0 percent.

In light of these findings, has your facility changed the cell phone policy? Would you be willing to share these changes?

Comment:
The provisional PDF of "Interference by New-Generation Mobile Phones on Critical Care Medical Equipment," an article by E.J. van Lieshout, S.N. van der Veer, R. Hensbroek, J.C. Korevaar, M.B. Vroom, and M.J. Schultz, to be published in the September issue of Critical Care 2007. In the article, the researchers conclude that, "Critical care equipment is vulnerable to EMI by new-generation wireless telecommunication technologies with median distances of about 3 cm. The policy to keep mobile phones ‘1 meter’ from the critical care bedside in combination with easily accessed areas of unrestricted use still seems warranted."

Additional Information:

Interference by New-Generation Mobile Phones on Critical Care Medical Equipment

http://ccforum.com/content/pdf/cc6115.pdf

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LabNet

Of Special Interest to Laboratorians/LabNet

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CLIA Waiver Granted by FDA for i-STAT® CHEM8+ Test Cartridge

The Office of In Vitro Diagnostics (OIVD) of the Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived status to the Abbott Point of Care i-STAT CHEM8+ test cartridge. The CHEM8+ test cartridge is a single-use, in vitro diagnostic test cartridge that measures sodium, potassium, chloride, total carbon dioxide, glucose, urea, creatinine, ionized calcium, and hematocrit in arterial, venous, and capillary whole blood samples. The CLIA waiver makes the handheld test cartridge more widely available for use to health care providers when a faster turnaround in results may be needed, such as in physicians’ offices, emergency departments, intensive care units, operating rooms, and outpatient clinics. The CHEM8+ test cartridge is the first i-STAT cartridge to receive a CLIA waiver.

FDA Clears Genetic Lab Test for Warfarin Sensitivity

On September 17, 2007, the U.S. Food and Drug Administration cleared for marketing a new genetic test that will help physicians assess whether a patient may be especially sensitive to the blood-thinning drug warfarin (Coumadin), which is used to prevent potentially fatal clots in blood vessels.

One-third of patients receiving warfarin metabolize it quite differently than expected and experience a higher risk of bleeding. Research has shown that some of the unexpected response to warfarin depends on variants of two genes, CYP2C9 and VKORC1. The Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test detects some variants of both genes.

"Today’s action offers physicians the first FDA-cleared genetic test for warfarin sensitivity, which is another step in our commitment to personalized medicine,” said Daniel Schultz, M.D., director, FDA’s Center for Devices and Radiological Health. “With this test, physicians may be able to use genetic information along with other clinical information to treat their patients.”

Warfarin can be a difficult drug to use because the optimal dose varies depending on many risk factors, including a patient's diet, age, and the use of other medications. Rapidly achieving the correct dose is important. Patients who receive doses that are higher than needed to correctly thin the blood are at risk of life-threatening bleeding. Those who receive doses that are too low may remain at risk of life-threatening blood clots.

Warfarin is the second most common drug, after insulin, implicated in emergency room visits for adverse drug events.

In August, FDA approved updated labeling for Coumadin, the brand name version of warfarin, explaining that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug. Manufacturers of generic warfarin are adding similar information to their products' labeling.

Physicians and other health care professionals who prescribe warfarin regularly check to see if the drug is working properly by ordering a test called the PT or prothrombin time that evaluates the blood's ability to clot properly. The results are measured in seconds and compared with the expected value in healthy people, known as the International Normalized Ratio or INR.

The Nanosphere test is not intended to be a stand-alone tool to determine optimum drug dosage, but should be used along with clinical evaluation and other tools, including INR, to determine the best treatment for patients.

FDA cleared the test based on results of a study conducted by the manufacturer of hundreds of DNA samples as well as on a broad range of published literature. In a three site study, the test was accurate in all cases where the test yielded a result; 8 percent of the tests could not identify which genetic variants were present.

The new test was cleared for use on the Verigene System, a clinical laboratory test system. Both products are manufactured by Nanosphere Inc., Northbrook, Ill.

FDA Licenses 15 New Blood Typing Tests
Tests help ensure safe blood transfusions for patients

On September 14, 2007, the U.S. Food and Drug Administration licensed 15 new blood typing tests that were previously unavailable in the United States.

These tests, known as blood grouping reagents, are used to determine the blood type of blood donors, an essential step in ensuring safe blood transfusion for patients. If mismatched blood is administered to a patient, it may cause a serious and potentially fatal reaction. To prevent such problems, people must receive compatible blood based on the results of blood typing tests.

The newly approved ALBAclone Blood Grouping Reagents include the common ABO and Rh tests, plus tests for rare blood types. The reagents are monoclonal antibodies, highly specific antibodies that ensure product uniformity and availability.

"The licensing of these reagents will provide more choice for blood establishments and transfusion services and may facilitate testing for rare blood groups," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "Licensure of these additional blood grouping reagents will help ensure a more stable supply of these tests, especially important in the event of a product shortage."

The reagents are manufactured by Alba Bioscience, Inc. of Durham, North Carolina.

FDA Approves Second West Nile Virus Screening Test for Donated Blood and Organs

The U.S. Food and Drug Administration announced on August 28, 2007, approval of a second test for the detection of West Nile virus (WNV) in blood and organs.

The cobas TaqScreen WNV test is an automated test that's able to detect the genetic material of the virus itself early in the infection. Such nucleic acid testing improves blood and organ safety, detecting whether donated blood and organs have been infected even before the donor's body has begun to produce antibodies against the virus.

Most often, WNV is transmitted to humans by mosquitoes. But WNV can also be transmitted by blood transfusion or organ transplantation from infected donors. While WNV infection is common in Africa, Asia, and the Middle East, it did not appear in the United States until 1999. Since then, WNV has become endemic in most of this country, with from 1 million to 3 million cases between 1999 and 2006, according to the Centers for Disease Control and Prevention (CDC).

"This action is the culmination of the dedicated efforts of FDA, our sister agencies, blood establishments, and manufacturers to bring donor screening tests to market for this increasingly common virus," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "As a result, blood centers and hospitals now have a choice of two FDA approved tests to screen for West Nile Virus in donated blood and organs."

Most people infected with WNV show no signs of the disease but about 1 in 150 to 1 in 350 infected people will develop serious symptoms, including encephalitis, an inflammation of the brain. Since the introduction of the virus, the reported number of human cases of serious WNV in the United States has grown steadily from 62 in 1999 to 4,269 in 2006.

WNV has been especially virulent this year. Although it is still early in the WNV season, 58 blood donors who are possibly positive for the virus have been reported to the CDC as of August 21, 2007.

The cobas TaqScreen WNV test is approved for the detection of the virus in plasma specimens from human donors of whole blood and blood components (plasma, red or white cells, platelets) and living donors of cells, reproductive cells and other tissues. It is also intended for use in testing plasma specimens of organ donors when specimens are obtained while the donor's heart is still beating. The test is not intended for use on samples of cord blood or as an aid in the diagnosis of WNV infection.

Approval comes as FDA is preparing guidance on the use of licensed WNV screening tests for blood donors.

The test is manufactured by Roche Molecular Systems Inc. of Pleasanton, California.




Additional Information:

For further details, refer to the Abbott Point of Care October 2, 2007, press release at

http://www.abbottpointofcare.com/istat/www/press/archive/press-releases/ABT_CLIA_FINAL_10-2-07.pdf

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KidNet

Of Special Interest to Pediatric and Neonatal Staff/KidNet

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U.S. Consumer Product Safety Commission Recalls About 1 Million Simplicity Cribs Based on Design Failures Resulting in Infant Deaths

On September 21, 2007, the U.S. Consumer Product Safety Commission (CPSC) announced a voluntary recall with Simplicity Inc., of Reading, Pennsylvania, of approximately 1 million cribs. These Chinese-made cribs, sold nationwide January 1998 through May 2007, have drop-side failures resulting from both the hardware and the crib design, which allow unintentional, incorrect installation. This faulty instillation can weaken the hardware and cause the drop-side to detach from the crib, creating a hazardous gap that can lead to entrapment and suffocation of infants. CPSC is aware of the deaths a 9-month-old child and a 6-month-old child, seven infant entrapments, and 55 other incidents involving these cribs.


Crib Bumpers Called Too Risky

A recent MedPage Today feature presented findings of a study on the value of baby crib bumper pads published in the September 2007 Journal of Pediatrics. The researchers concluded that the risk of death, be it small, outweighs the value of bumper pads as a cushion against bumps and bruises.

In an analysis of death certificates of children aged 1 month to 2 years in the U.S. Consumer Products Safety Commission database from 1985 through 2005, researchers found 27 bumper-related suffocation and strangulation deaths. This finding is at odds with the conclusion from the Juvenile Product Manufacturing Association in an unpublished review of the same database. The finding confirms, however, concerns raised by the American Academy of Pediatrics. In a companion editorial, Rachel Y. Moon, M.D., of Children's National Medical Center in Washington, D.C., wrote, "Ever since the first crib bumper pads were sold, they have held a seemingly irresistible appeal to new parents," she said, but physicians "must continue to remind parents that when it comes to sleep time for their infants, soft and cozy do not equal safe."

Additional Information:

Consumer Product Safety Commission Recalls About 1 Million Simplicity Cribs Based on Design Failures Resulting in Infant Deaths
http://www.cpsc.gov/cpscpub/prerel/prhtml07/07307.html

Crib Bumpers Called Too Risky
http://www.medpagetoday.com/Pediatrics/Parenting/tb/6750

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HomeNet

Home Use of Devices Creates New Challenges for FDA, Manufacturers

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Against the backdrop of the September 17-18 Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and University of Houston conference on the safe migration of medical devices into the home, Medical Devices Today reported on the growing concerns of FDA, manufacturers, and other stakeholders as patients and devices move out of the hospital and into the home.

The range of complexity in home care medical equipment runs from canes to laptop-sized ventilators. With home health device use anticipated to double over the next 4 years, in-home product use and regulatory oversight must be addressed by FDA and manufacturers in the interest of safety. In remarks at the conference, CDRH Director Daniel G. Schultz said, "Despite the fact that there is a lot of activity in this area and we've seen a lot of progress, I think we all want more devices that are designed and specifically tested for home use," adding, “We want better and more consistent review criteria.”

Among FDA and manufacturer concerns are the few restrictions governing physicians’ ability to send patients home with devices not labeled for home use and the industry’s obligation to design and market with a close eye to human factors. Susan Morris, vice president for government affairs for Kinetic Concepts, stated that as manufacturers redesign institutional products for home use, they should remove all unnecessary functionality and add features that accommodate patients and caregivers in prescribed protocols. The importance of manufacturer control over product distribution is another concern, and industry and regulatory experts predict that manufacturers will increasingly become suppliers.

Morris believes that legacy devices are particularly worrisome. These are old devices, many from health care institutions and most not produced for home use, that may lack instructions or may have only clinician (versus consumer) instructions. Such devices are and increasingly will be available through unmonitored online markets. Further, recent Medicare legislation requires patients to purchase certain durable medical equipment after having rented it, and this policy will drive the sale of used devices and make maintenance and correct usage of devices in the home even more difficult.

In the near term, FDA will invite manufacturers to participate in a new, voluntary, online labeling repository for home-use devices focusing on infusion pumps and will launch HomeNet, the MedSun subnetwork that will track adverse event reporting related to home-use devices.

Additional Information:

Read this article in full at
http://www.medicaldevicestoday.com/2007/09/home-use-of-dev.html

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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 July 1 through August 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.
*2 month period for November Newsletter

ANESTHESIOLOGY

Device: Ventilator, EvitaXL
Manfacturer: Dräger Medical AG
Problem: The ventilator displayed "device failure" then shut itself off. The patient was on noninvasive ventilation mode and was taken off the machine promptly by nursing staff and placed on oxygen. The ventilator was replaced with another unit. When Clinical Engineering staff looked at the ventilator, it displayed several error codes: 02.00.002, 10.99.111, 10.99.112, 11.01.011, 12.01.011, and 13.01.040. All these codes have different meanings, but, according to Dräger, when grouped together, they point to an issue with either the air or O2 high pressure solenoid valve. The valve has locked up and possibly caused the -15 volts to drag down, causing the ventilator to go into reboot.


Device: Catheter, Bronchial, Single-Use Nonbroncho scopic Broncho alveolar Lavage Catheter (16 Fr diameter 5.33 mm length) Model# REF 141 Lot# 392141 and 397902
Manfacturer: Kimberly Clark Corporation
Problem: In the process of instilling a Mini-BAL Introducer (part of the nonbronchoscopic bronchoalveolar lavage catheter), the introducer section of the inner catheter tore and disconnected from the site. The procedure was immediately terminated, with no harm to the patient. The Kimberly-Clark representative stated that other users have reported the same issue with the catheter. During the investigation, all catheters in stock were inspected, and several of these were noted to be defective. Defects were associated with two lot numbers. The Respiratory Department and the company determined that for the catheters to be safe for use, each catheter should be inspected prior to use. Any defects should be reported. Within lots 392141 and 397901, 140 catheters were removed immediately, with 45 replaced, and more are being shipped to replace the total number. The company representatives feel that this is an urgent matter, and all appropriate staff have been notified and are mobilized and working diligently to resolve this matter.


Device: CPR Bag Lot# 06184004, 06072004, 06348187, 06345187 Catalog# 10-55187
Manfacturer: Mercury Medical
Problem: The Clinical Engineering Department performs an acceptance test on every resuscitation bag before the product is placed into use by the hospital. Nine bags have recently failed our inspection. The reservoir bags have had several cuts 2–4 inches long. These cuts tend to be located at or near the fitting that attaches to the hand-operated bag.


Device: Humidifier, Ventilator, Water Float in Ventilator Heater Chamber Circuit Model# MR 290 Lot# 061204 1630 DL
Manfacturer: Fisher & Paykel Healthcare Corporation, Ltd.
Problem: Prior to this incident, the ventilator circuitry had just been changed. The sterile water bag had just been spiked to fill the heater/humidifier water chamber. The float that controls the water level was stuck. This caused the water to fill the water chamber and flow up into the circuit to the patient, causing the patient to desaturate and become bradycardiac and cyanotic. The patient was immediately taken off the ventilator and manually ventilated until fully recovered, and the water chamber was replaced. Two days later, the malfunctioning equipment was reported. The quality team is following up, and they have reported the incident to the manufacturer. According to our Respiratory Therapy Department, this type of failure is not easily identifiable until the sterile water is added to the circuits, which generally occurs after the patient is on the ventilator. Additionally, depending upon the speed and nature of the defect, it may take anywhere from seconds to hours for the water to fill the heater chamber to a level that will direct water toward the patient.


Device: Ventilator Model# 840
Manfacturer: Puritan-Bennett Corporation
Problem: The ventilator alarm and external room alarm were sounding. The patient's ventilator read "INOP." The patient was immediately removed from the ventilator and bagged with 100 percent oxygen. The RN then assumed responsibility for ventilating the patient while the respiratory therapist exchanged the ventilator. The patient’s vital signs were stable throughout incident. The ventilator was pulled from service. A problem was found with the CPU board, which was then replaced.


CARDIOVASCULAR

Device: Hemodynamic System, Catheterization, SE Horizon Model# Console 9000
Manfacturer: Mennen Medical Ltd.
Problem: During a cardiac catheterization procedure, the Mennen hemodynamic monitor failed and would not show any EKG tracing or heart rate. This equipment had screen lockups with the error message "no connection from CFE (catheterization laboratory front end)" during at least four other catheter laboratory procedures earlier this year. The patient was not harmed. A portable monitor was immediately used for pulse and EKG monitoring, and the Biotechnical Department has been unable to duplicate the screen lockups and the disappearance of EKG tracing and heart rate. The machine would work if the CFE button were reset. A few months ago, a Mennen field service engineer applied a patch for Sun Blade systems that use dual video cards. One is built onto the mother board, and one is added to the video card. Since the patch was applied, we have continued to have the same problems intermittently on five pieces of this equipment.


Device: Seal System, HEARTSTRING II Proximal Seal System Model# HSK-2038 Lot# 7040581, 7020681, 7041181
Manfacturer: Guidant Corporation
Problem: The patient was undergoing a coronary artery bypass graft (CABG) procedure. A total of seven Guidant HEARTSTRING II Proximal Seal System devices were opened for the case, and only one was used. Two of the devices were unraveling when opened. Three were folded and inserted into the deployment device per the manufacturer's recommendations, but these unraveled prior to use. One was placed and ready for deployment, but it did not deploy out of the device. The seventh device was successfully inserted and used in the patient.


Device: Guidewire, Vascular, Wholey Hi-Torque Modified J Lot# 7012691 Catalog# 50110
Manfacturer: Tyco Healthcare/Mallinckrodt
Problem: During a coronary angiography, left heart catheterization, left ventriculogram, and arterial and venous bypass graft angiograms, the 4 French 12 cm sheath introducer was inserted in the right femoral artery. The patient has peripheral vascular disease. The 0.035 mm J tip 145 cm guidewire was inserted, followed by a 4 French straight pigtail diagnostic catheter and 4 French JL 4.0 diagnostic catheter, 4 French 3 DRC diagnostic catheter, and a 4 French internal mammary diagnostic catheter. During the procedure, the distal end of the Wholey guidewire separated at the gold connector, and this was visualized on fluoroscopy. The guidewire did not come apart. It was removed and replaced with another 0.035 Wholey 145 cm guidewire, and the procedure was completed without complications. The patient was discharged to home 1 day after the procedure in good condition. The guidewire, packaging, and an unused sample from the same lot number were saved for investigation by the manufacturer.


Device: Transducer Kit, Blood Sampling, TranStar Lot# 36K16M085, 1147039 Catalog# MX9537T
Manfacturer: Smiths Medical
Problem: Three events were reported in which the yellow blood-drawing port came apart from the product when being used in the NICU. In one incident, the syringe also disconnected from the tubing. Products from two different lot numbers were being used at the time of the incidents, so the specific lot number for each product could not be identified. There was no patient harm in any of the reported incidents, and the manufacturer is aware of and is investigating the reported incidents. No further information is available at this time.


Device: Monitor, Physiological Dash 5000
Manfacturer: GE Medical Systems Information Technologies
Problem: Twenty-eight GE Dash 5000 cardiac monitors were purchased approximately 18 months ago. The monitors also track oxygen saturation. The monitors pickup and alarm at the slightest modification, regardless of duration, suggesting that the neonate is sicker then he/she really is. We have been working with GE seeking a longer delay that will verify if the O2 saturation is simply a spike or a longer O2 decrease. GE acknowledges the problem and has advised us that they have to run any change past the FDA, and that it will be October before a fix is available. This issue causes a possible longer length of stay, worry for parents, and additional tests.


Device: Catheter, Intra-Aortic Balloon, Ultra 8 Lot# MF 7033808 Catalog# IAB-05840-U
Manfacturer: Arrow International, Inc.
Problem: The patient went to surgery for a mitral valve replacement. The patient returned to surgery later in the afternoon with postoperative bleeding at the operative site and then returned to the surgical intensive care unit on an intra-aortic balloon pump. During the night shift, the balloon console alarmed continuously. The console was changed two times without resolution of the problem. The physician was called to the bedside and was about to change out the intra-aortic balloon catheter because it was working intermittently for about 10 seconds at a time. The patient underwent cardiac arrest during the time the balloon was intermittently functioning. The patient was resuscitated, and a new balloon was inserted. Currently, the patient remains unresponsive in critical condition and appears to have sustained permanent neurological damage. We have had several other reported issues with this same fiber-optic catheter over the last several months (balloon failures, various alarms), which have recently been reported to the device manufacturer. We have obtained lot numbers from the shipments several months ago. If these lot numbers are needed, we have them, but we have not saved the outer wrappers from the devices involved in these past events to confirm actual lot numbers. Arrow International, Inc., stated that the company has not had a reportable number of complaints involving this product. Their representatives feel the lack of wire reinforcement in this particular catheter may be leading to kinking, thus generating the alarms. The company has offered additional troubleshooting training for users.


Device: Electrodes, ECG, Neonatal Lot# 704710, 708207 Catalog# 13953A Other Device# RMA MC07071605
Manfacturer: Philips Medical Systems
Problem: The ECG neonatal electrodes have bright aqua/baby blue-colored spots on them, which were caused by bare metal wire fragments in the gel. The problem was immediately obvious because of the change of color from white to bright blue on the pads, so the electrodes were not used; however, the concern is that if they had been used, they could have damaged the extremely fragile skin of premature or newborn infants. This color change occurred once before, approximately 14 months ago, and was reported to the company.


Device: Syringe Kit, Contrast Injector, ACIST Lot# 0307B, 0047B Catalog# SKU 014612 Other Device# CMS 2000 Injector
Manfacturer: ACIST Medical Systems, Inc.
Problem: Contrast injector syringes are fracturing at the contrast port. This has occurred several times. The manufacturer is aware of this problem and is evaluating the reason for the failures. When using the A2000 syringe kits for the ACIST Angiographic System it has been suggested to use a 3Fr–5Fr catheter, flow rates of slower than 10 ml/second, and rise times longer than 0.6 seconds.


GASTROENTEROLOGY/UROLOGY

Device: Biopsy Gun, Inter V BioPince Model# 360 1080-01 Lot# 71691HOM
Manfacturer: Angiotech
Problem: Normally, there are two core biopsies acquired for an ultrasound guided liver biopsy. In this case, six attempts were made with three separate core biopsy instruments, with no samples obtained. The fourth instrument did obtain a small but satisfactory core. One more attempt was made with the same instrument to obtain a second satisfactory core, but it again came up dry. The representative has contacted the company representative several times without a reasonable resolution. Since more than one patient incident of this type has occurred while using this biopsy instrument, the physician's assistant has requested that no more core liver biopsies be scheduled until this problem is resolved. There has been no patient harm. We do not have the device, but they came out of the lot numbers that we still have. (A similar MedSun report was received during the selected reports timeframe involving the same model device and Lot# 70311E20.)


Device: Dialysis Machine, Continous Renal Replacement Therapy PRISMAFLEX
Tubing Set, Dialysis Model# M100 Lot# 06L1569
Manfacturer: Gambro Renal Products, Inc.
Problem: The patient was receiving continous venovenous hemodialysis (CVVHD) in his room when the alarm sounded. The RN answered the alarm, which displayed "Low Pressure Alarm" on the screen, with instructions to check the patient and check for connection problems. The RN verified that the patient was still properly connected to the CVVHD machine and that all connections were correct. At this time, the RN hit “Continue,” as directed by the CVVHD machine after verification of the connection to the patient. Approximately 5–10 minutes later, the CVVHD machine alarmed again. Another RN on the unit went into room and called out for help. The patient's RN then went into room. There was blood on the floor and the machine displayed "Patient Self-Disconnect"; however, the CVVHD machine tubing never became disconnected from the patient. The RN assessed the patient. The patient was hemodynamically stable throughout. The RN disconnected the patient and stopped the machine, as directed by the dialysis RN. The RN found a small white piece of rubber under the patient's bed and collected it in a sterile cup in case this is part of the CVVHD machine that was faulty and leaking blood. The patient remained stable throughout. We believe that the filter partially clogged, causing pressure to build up and the tubing set to fail. Gambro will evaluate the product.


GENERAL HOSPITAL

Device: Patient Lift, Golvo 7007 ES Other Device# 2000010
Manfacturer: Liko, Inc.
Problem: The patient was ready for discharge to home status after percutaneous endoscopic gastrostomy tube placement. The patient was unable to stand due to a history of strokes, so the staff used lift equipment to get the patient from the bed to her wheelchair. Staff report that as the patient was lifted from the bed and to the chair, the sling started to slip out from under the patient, allowing her head to fall back. The staff tried to ease the patient to the floor while she was still partly in the lift device, but her head fell back and struck the bottom support beam of the lift approximately 2 feet from the floor. The patient sustained a lump to the back of her head, but she had no loss of consciousness, and her vital signs were stable. She had a history of coumadin use. The physician was notified, and a head CT scan was done, and the results were normal. The patient was admitted for observation and was discharged the following day to home. Her neurological assessment remained unchanged throughout the observational stay. The lift equipment and sling were inspected, and both functioned appropriately. We believe this is user error. The only way we and the representatives were able to reproduce this event was by applying the leg straps to the sling bar first instead of the shoulder straps. Also, the sling size appears to be too large for this patient, which contributed to the event. Although staff were trained and experienced in using this equipment, they felt that it would be helpful for the manufacturer to consider making the shoulder and leg loops on the sling different colors as a secondary visual cue to make sure the device is used according to the manufacturer's instructions.


Device: Tubing, IV, Patient Controlled Analgesia, Epidural CADD Yellow-striped Administration Set Lot# 126x46 Catalog# 21-7339
Manfacturer: Smiths Medical
Problem: The patient-controlled analgesia (PCA) epidural tubing was attached to an IV pump. The Assistant Director of the Postanesthesia Unit is familiar with the epidural and IV PCA medication tubing problem because she had similar problems in the last hospital where she worked. The ends that connect to the catheter on the tubing for administration of the epidural and on the IV PCA medications tubing are very similar. They have identical male luer lock connectors that easily fit into the connector on the epidural or on the IV PCA catheter. The epidural tubing has two yellow stripes running along its length. The IV PCA tubing is clear. If the epidural tubing is rotated, there are positions at which the yellow strips “disappear” and the tubing looks clear. The middle portions of the two tubings are different, but sometimes these sections are hidden by the bedding or the patient’s position. Given the consequence of a patient’s receiving a large IV bolus of bupivicaine, potentially lethal cardiac arrhythmia, and the fact that this problem has already occurred with two patients, we are considering implementing a Timeout policy, which would allow us to verify that we are giving the correct medication via the correct route when epidural or IV PCA pain medications are being set up.


Device: Pump, Syringe, Medfusion 3500
Manfacturer: Smiths Medical
Problem: The patient was an active toddler receiving milrinone at a rate of 0.5 mcg/kg. The patient's mother left the room, and when the nurse went to check on the patient, he/she found that the syringe of milrinone had been removed from the pump by the patient and was in his hand. The nurse verified and confirmed that no extra medication had been delivered. This pump does not lock; instead, the syringe is clamped into the pump. To avoid this in the future, a locking device attachment that could be affixed to the pumps would be helpful for use in the pediatric population.


Device: Pump, IV Symbiq Infusion System
Manfacturer: Hospira Global Medical Affairs
Problem: There have been intermittent problems with the Symbiq Infusion System in which the pump stops infusing, the alarm sounds, and an error message (S321/S421) appears on the screen. This problem was reported to Hospira. According to Hospira, when the device triggers this alarm, the device is designed to stop infusing at the affected channel, and a continuous, high-level alarm will sound until the clinician responds. There have been no adverse outcomes related to this malfunction. Staff removed the malfunctioning device from service and obtained another pump.


Device: Pump, IV, Module ALARIS Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: The channel through which Levophed was running turned off by itself with no alarm or warning. The patient's blood pressure dropped to 60/20. The cardiac monitor alarmed, which is how the malfunction was discovered. Medication was restarted.


Device: Bed, Hospital, Florence Electric Bed Model# FL23E
Manufacturer: Stryker Medical
Problem: The hospital had ordered two new "junior" (pediatric) electrically operated beds. When delivered, it was noted that the beds have two accessory plug-ins for patient equipment at the foot. These patient device accessory outlets are not labeled as to any safety concerns. This manufacturer has adult beds that have accessory outlets that require labeling not only for electrical safety but also for use safety, such as "Do not use for life saving equipment," which indicates that the outlets are not battery-supported. No such labeling is on the pediatric bed. It appears that the design of the bed would indicate there was no battery, but this is presumptive knowledge on the part of the user.


Device: Needle, Huber, SafeStep Lot# D630505 Catalog# LH0030
Manufacturer: Specialized Health Products, Inc.
Problem: The product malfunctioned on five occasions. The second event was an occlusion; the others were leaks where the tubing connects to the needle. Air entered the tubing during a blood aspiration during the most recent event. The manufacturer is having problems with some of the products made in 2006 and is swapping out these products.


Device: Needle, Huber, MiniLoc Safety Infusion Set Model# 0632010
Manufacturer: Specialized Health Products, Inc.
Problem: The patient was discovered in bed with her MiniLoc Safety Infusion Set huber needle that is used to access her implantable port separated. The patient was receiving 5-FU (chemotherapy drug) at the time, and there was some of the chemotherapy on her bra, gown, and bedding. The patient's old huber needle was removed. This is the tenth incident involving this same model of huber needle in the past 6 months at our hospital. One of the devices was sent to the manufacturer, and another one is at our facility. The packaging was thrown away in all instances. Inspection of all devices showed that the tubing portion of the MiniLoc became unglued from the luer lock portion, causing medication to spill out of the tube onto the patients. None of the patients involved was reported to be combative, so it appears that the tube just slipped out of the luer lock portion after the glue dissolved in some way. Because these devices are primarily used for chemotherapy drugs, the drugs could be caustic to the skin and therefore pose a patient safety risk. The manufacturer was contacted and we were told that their representatives do not know why this is occurring, and that they need to do more research. The manufacturer sent us replacement devices in that instance.


Device: Tubing, IV, Outlook 200 Model# 200
Manufacturer: B. Braun Medical Inc.
Problem: An antibiotic was hung as a piggyback medication into primary line, which was on a pump. The pump was running in piggyback mode with 223.4 ml to be infused. The primary bag that previously held 200 ml now was at 480 ml. The pump settings and bag height placement were correct. The upper backcheck valve of the tubing was found to be folded over. It appears that the backcheck valve of the primary IV set failed, and the antibiotic ran into the primary IV instead of going into the patient.


Device: Tubing, IV, Extension Set, Mini Bifuse Lot# 36j25m032 Catalog# MBF30
Manufacturer: Smiths Medical
Problem: The patient's Medex Mini Bifuse disconnected from the IV tubing. The Mini Bifuse was connected to the central venous line (CVL). This disconnection caused blood to flow out of the CVL. This was the second patient today whose Medex Mini Bifuse disconnected by itself. Product issue is the question.


Device: Bed, Hospital, Crib Model 2000
Manufacturer: HARD Manufacturing Co., Inc.
Problem: Staff noted that the wheel on the crib would not turn without significant effort. Upon closer examination, the Biomedical Department discovered that three out of four of the screws had fallen out of the bracket that holds the wheels to the frame of the crib. HARD Manufacturing was contacted and recommended that a threadlocker be added to all wheel bracket mounting screws on all affected cribs. (It appears that this was not done during the assembly process.) Our facility has 10 of these cribs. All were checked. Four, including this one, had screws that fell out. A threadlocker was added to all of the screws. No harm to any patients.


Device: Pump, IV, Module PC Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: The ALARIS pump and the channel in use "burned out." The staff noted that one pump channel had malfunctioned, so the channel was changed out; however, there was no improvement. At this time, the staff noticed that the pump connections had shorted out and a burning odor was present. The pump was removed from service, and the medications were transferred to a new pump. There was no patient harm as a result of this malfunction.


Device: Pump, IV, Module PC Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: Mid-infusion, the pump channel malfunctioned. An insulin drip at the rate of 1.5 units/hour had been running through the channel for approximately 2 hours. The pump had two other channels set up and programmed, but they were not running. Approximately 30 minutes before the "CHANNEL ERROR" message was displayed, a phenylephrine drip had been started without problems. At the time of failure, no new channels were being started or added to the pump. The pump was plugged into the extension outlet, which was plugged into the wall. With the insulin infusion plugged in, and without warning or preceding errors codes, a message screen showing "CHANNEL ERROR" appeared, with additional text reading something to the effect that the pump needed to be taken out of service. No error code numbers were displayed (which were specifically looked for). Extension cords are used in the operating rooms, they are yellow in color and either a simple three-outlet strip or a larger, boxy-type contraption with a metallic face. No harm befell the patient, because the incident was readily detected, and the insulin was immediately switched over to a new pump.


Device: Pump, IV, Module PC Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: The failure of the ALARIS pump is described as follows: The call team was assembled for an emergent cardiac case for a patient in cardiac arrest with a presumed massive pulmonary embolism; the patient was coding when he/she arrived on the floor. The doctor programmed the ALARIS pump for the infusion of epinephrine and norepinephrine at high dosages. About 10 minutes later, the doctor happened to look at the ALARIS pump and found that it had shut down without any warning or audible alarm. There was a red light flashing on the front of the pump, but because every member of the call team was busy resuscitating the patient, no one saw it. It remains unclear how long the pump had not been infusing. In this incident, the problem was not due to a battery problem, because the machine was plugged in at the time.


Device: Pump, IV, Module PC Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: A secondary medication was to be programmed. The RN pressed the "Secondary Med" button. When the button was pressed, the entire pump shut down, flashed red, displayed "System Error," and then shut down the entire pump. All channels were needed, because this was an ICU patient with multiple medications running. All medications were reprogrammed onto a new pump.


Device: Pump, IV
Manufacturer: ALARIS Medical Systems, Inc.
Problem: The ALARIS pumps have a main pump unit (or CPU) which provides the infusion controls as well as the Guardrails software features. Attached to these are the various pump modules (standard IV or syringe pumps) that have the mechanical means to infuse medications. There is an edge connector with a number of pins that provides the electrical connection/communication interface between these two devices. We have encountered multiple device problems in which fluid intrudes this connection and creates a short, which then causes a variety of different failures, ranging from error codes, inappropriate or absent communication, burning odor, to smoking of the devices. The failures are dependant on the amount of fluid, the duration of time in which the fluid has infiltrated the connection, and the type of fluid that is present. ALARIS has not initiated any field notification regarding this specific issue, but the company has manufactured a new connector, which it is sending as a replacement part. The design of the connector appears to be the same and the old one, and we have a request in for more details on the specific change criteria to this in order to see if this is related to the fluid intrusion issue. Staff members are currently testing each device to ensure proper connectivity when a pump is received for repair, in addition to the annual scheduled preventative maintenance check. It should also be noted that we have started to install the latest Guardrails update today (Version 8), and we are testing the connection on each pump after the software upgrade is performed. A notice to staff from the nursing education team will be released regarding this issue, and an additional notification will be posted regarding checking the quality of the pump connections prior to use and keeping fluids away from the top of the case. Photographs of the connectors on some of the pumps have been taken to use as a visual representation in this message. I will follow up when I hear back from ALARIS regarding these continuing issues.


GENERAL SURGERY

Device: Electrosurgical Unit, ForceTriad Energy Platform
Manufacturer: ValleyLab
Problem: We implemented these new electrosurgical units (ESU) within the last month and experienced three problems with the devices: 1. When using the bipolar device, the staff plugged in the double-pronged bipolar cord and noted that the connection receptacle and prongs would not stay connected (the fit was too loose). The Surgical Team had to discontinue use of the ESU device and delay the surgery in order to locate an older ESU unit for the procedure. 2. During an ectopic pregnancy case, staff used a needle laparoscopic electrode, which has a monopolar plug, and a "dummy" return electrode monitor (REM) plug. The device would not work during this emergency surgery, which caused a delay for the patient while the staff located another unit. We consulted with the vendor representative, and he said that the company was aware of the problem, because the newer ESU model required "true REM capability" in order to work. We were not informed of this issue when we purchased and implemented these devices. 3. On a third case, the plug for the bipolar Bovie fit snug in the connection, but the unit only worked intermittently when the bipolar was activated.


Device: Handpiece, ESU, Vessel Sealing Ligasure TYCO Ligasure V, 5 mm Sealer/Divider Model# LS1500 Lot# 1259100
Manufacturer: ValleyLab
Problem: During a laparoscopic nephrectomy procedure, a small wire was found protruding from the end of the Ligasure handpiece (Model# LS1500 Lot# 125910). The device was removed from the field. All lots were pulled from the core. This is the third occurrence involving four device malfunctions.


Device: Mesh, Surgical, PelviSoft Acellular Collagen BioMesh Lot# 06B15-9
Manufacturer: Bard Urological Division of C.R. Bard, Inc.
Problem: The patient had complications (abscess and inflammation) at the site of a previous surgery where mesh had been implanted. The abscess was cultured, and no growth resulted. The mesh was surgically removed 5 months later.


Device: Aortic Punch Lot# 70730-1 Other Device# MDP-52K
Manufacturer: Teleflex Medical
Problem: The patient was undergoing a coronary artery bypass graft (CABG) procedure. When the disposable aortic punch was positioned and fired to make a hole in the aorta for attachment of the graft, the device misfired. Instead of making a hole, it made a tear. The device was positioned in the same place and refired, and an adequate hole was made. The physician reported that since the original manufacturer of this device was bought out, the punches made by this device do not cut as cleanly as they should.


Device: Bed, Surgical, Quantum Surgical Table Model# 3080RL
Manufacturer: STERIS Corporation
Problem: The patient, undergoing a laparoscopic robotic-assisted prostatectomy, was positioned in steep Trendelenberg’s position on the STERIS Quantum Surgical Table. The surgeon reported that he could not move the robotic arms, and he noticed that the bed was spontaneously moving itself back to a level position. The robot was undocked from the patient and moved up, away from the patient. A regular laparoscope was inserted to assure no injury occurred and to reinsert trocars. No injury was noted. The procedure was completed. The patient was discharged to home in good condition on postoperative day 3. At the time the surgical bed moved, no one was near the bed controls. The bed moved on its own. The bed was removed from service after completion of the procedure. Fluid was found in the bottom of the table. The manufacturer found a leaking hydraulic tilt cylinder from deteriorated seals. The tilt cylinder was replaced and tested. Maintenance is scheduled twice yearly and had been performed less than 1 month prior to the event.


LABORATORY/DIAGNOSTIC TESTS

Device: Glucometer SureStep Flex Model# L6132SB00012
Manufacturer: LifeScan, Inc.
Problem: The glucometer read 32; when the sample was rechecked with another glucometer, the sample read 168. The patient was asymptomatic. The glucometer was sent to the laboratory that oversees the maintenance.


Device: Glucometer ACCU-CHEK Inform Model# 2001201
Manufacturer: Roche Diagnostics Corporation
Problem: The blood glucose result on ACCU-CHEK was 166, and the result from the laboratory was 259. Both tests were run on the same blood sample. ACCU-CHEK controls were completed, and no problems were identified.


Device: Urine Pregnancy Test Kit, Sure-Vue Lot# HCG7040077 Catalog# 23900530
Manufacturer: Fisher HealthCare
Problem: This is one of four instances in which patients had four false-positive pregnancy results when the urine pregnancy test kit was used. The serum pregnancy test was negative. The occurrence for these patients was over a course of a few days. As a result of the false-positive tests, all patients received sonograms. The manufacturer was contacted, and area hospitals were called to see if they were experiencing similar problems. The manufacturer sent a different lot to the facility; again, the urine pregnancy test kit gave four false-positive results for the same initial samples. The manufacturer then sent another lot that was received today. The test kit was retested on the initial sample, and it worked.


OBSTETRICS/GYNECOLOGY

Device: Catheter, Ablation, Endometrial, NovaSure Impedance Controlled Ablation System Lot# NS2000
Manufacturer: Cytyc Surgical Services, Inc.
Problem: When the surgeon was using the device, the vacuum light came on three times, and ablation was incomplete. A new disposable device was opened, and the same thing happened. The surgeon was able to complete the surgery with another device. There was no patient injury. The Biomedical Department verified performance of the NovaSure device, and no problems were found. According to the service manual, the vacuum LED will illuminate when a blockage is detected in the disposable device or the connection tubing, or when the system has a leak. There are several situations in which this might be created: 1) an over-dilated cervix with poor contact between the cervical collar and the external OS; 2) a poor luer connection to the vacuum feedback or suction flush port; 3) a poor attachment of the desiccant tube to the suction tubing; 4) an obstruction in the disposable device tubing; 5) an obstruction in the disposable device. One week after the event, the ambulatory facility staff tried the device again in another procedure with the sales representative present, and there were no further problems. One month after event, no other problems have been reported. No followup is required. Scheduled preventive maintenance will continue on a semiannual basis.


Device: Catheter, Ablation, Endometrial, NovaSure Lot# 07E10H Catalog# 615202
Manufacturer: Cytyc Surgical Services, Inc.
Problem: Physician performed an endometrial ablation. On removal of the device, she noted that the gray tip of the device had melted and appeared sharp. The patient was examined for injury and none was found.


PHYSICAL MEDICINE

Device: Pad, Hyperthermia, Energy Transfer Pad Lot# 392105 Catalog# 00315-05Z
Manufacturer: Kimberly-Clark Corporation
Problem: Kimberly-Clark warming pads were being used on the patient during surgery. The side tapes on the pad were removed gently from the patient's sides. There was redness and weeping on both sides where the tape had been. Nursing was informed of the injury. Per the medical record, there were stage II skin tears to the chest laterally (axilla to hips).


Device: Attachment, Wheelchair, Traveler Model# B10320E
Manufacturer: Everest & Jennings
Problem: The hospital ordered 65 Everest & Jennings "Traveler-20" Wheelchairs from Graham Field. Along with the wheelchairs, we ordered the IV pole and oxygen tank holder combination attachment for the wheelchairs. The day after placing the wheelchairs with attachments into the hospital, a security guard verbally reported accidentally bumping into the IV pole attachment, which was set at eye height, and which poked him in the eyeglasses he was wearing. After reviewing the IV pole loops design, we realized that they poke out horizontally and could easily poke someone in the eye. Also, the attachment is designed to sit only at three different heights, all of which could be at one's eye level, depending on the person’s height.


RADIOLOGY

Device: Software, Imaging e.soft v. 3.5
Manufacturer: Siemens Medical Solutions USA, Inc.
Problem: A radionuclide ventriculogram multiple-gated acquisition scan was performed in an imaging room with an EKG trigger set on negative polarity. The negative polarity caused the gated acquisition to start and end each image on the S-wave instead of the R-wave. The software could not correctly identify the end diastole (ED) frame to properly calculate the ejection fraction (EF). The EF results of several patients were 0–15 percent lower than a manually recalculated EF. The software should have been able to identify the ED frame by searching throughout all 32 frames of the acquisition. The current software only identifies the ED using the first 16 frames.


Device: Magnetic Resonance Imaging Achieva 1.5T
Manufacturer: Philips Medical Systems
Problem: The software key that would have enabled us to complete the appropriate scan on the patient expired. Philips Medical Systems had been notified 4 months prior to the event that one of the software keys on the system was going to expire on a specific date. The system does not identify what key is going to expire, so the technical staff did not know what systems were supported by the specific software key. Our facility had been assured by Philips that the update would be installed by them before the expiration date. Unfortunately, it was not, and the staff had no way of verifying which studies or types of sequences had been done. When Philips was notified of the event, the representatives claimed that they erroneously read the expiration date using European date convention rather than the U.S. date convention, so the month was read as the day and the day as the month.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With da Vinci Surgical Devices

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Over the past 4 years, MedSun has received 26 adverse event reports associated with the da Vinci computer-assisted surgical device manufactured by Intuitive Surgical, Inc. The reports were submitted by 15 hospitals between January 2004 and May 2007. Twenty-three of these reports were selected as representative of the adverse events for inclusion below. The most commonly reported device problems were instrument breakage, particulate matter falling off instruments, and failure of the electromechanical arms to manipulate instruments. The patient injuries listed below were reported in 7 of these 26 reports.

•3 procedures converted to open surgery
•2 unexpected cardiopulmonary bypasses required
•1 additional incision site created
•1 tip of a needle left in patient

These MedSun reports contributed to FDA awareness of the device problems. FDA followup with the manufacturer resulted in the manufacturer’s voluntary recalls of the affected devices for their improvements.

[Note: The term "robotic" used in the reports is the common name for “computer-assisted” equipment. The latter term is preferred by FDA because the device is operated by a surgeon. The reports have been edited for clarity.]

1
Device Type: da Vinci, Monopolar Cautery,
Device Identifiers: Hot Shears (Mono Curved Scissors) Catalog# 400179; Lot# 0112061835
Event Description: A surgeon was performing a laparoscopic robotic-assisted myomectomy. During the procedure, a piece of the orange tube extension broke off the monopolar curved scissor. Another monopolar curved scissor was given to the surgeon to use, and the orange tube extension on that instrument broke into pieces. The silicone tip cover was not used with either of the monopolar curved scissors. Our initial thought was that the damage was caused when the electrosurgical unit was activated without the silicone tip cover. The Intuitive Surgical, Inc., engineer informed us that the tip cover adds support to the end of the tube extension. When the instrument is cutting, it puts additional stress on the end of the tube extension. The engineer also informed us of the importance of using the silicone tip cover to prevent alternate site burns. Staff who were trained by the company clearly understood that the silicone tip cover provided insulation to prevent burns, when used for cauterizing, but did not have any knowledge of the silicone tip cover’s support for the monopolar curved scissors. Our evaluation of the monopolar curved scissors is that the failure was based on human error and the design of the instrument. The monopolar curved scissors were returned to Intuitive Surgical, Inc., for evaluation. Our recommendation for future designs would be for the company to develop a better product that takes into consideration the possibility of failure.

2
Device Type: da Vinci S, Monopolar Cautery, Curved Scissors, Hot Shears (Mono Curved Scissors)
Device Identifiers: Catalog# 420179; Lot# 290101724, Other Device# Version 4
Event Description: The patient underwent a robotic-assisted total laparoscopic hysterectomy with bilateral salpingo-oophorectomy for fibroid tumors. During the procedure, one of the blades on the robotic scissors broke off.

3
Device Type: da Vinci S, Monopolar Cautery, Curved Scissors, Hot Shears (Mono Curved Scissors)
Device Identifiers: Catalog# 420179; Lot# 70806158
Event Description: During the procedure, some small, black particles were noted as debris from the da Vinci monopolar curved scissors. The wound was irrigated, and black particles were suctioned out by the surgeon.

4
Device Type: Ultrasonic Energy Instruments, Harmonic Curved Shears With Insert
Device Identifiers: Catalog# 400169-05; Lot# C6123
Event Description: The movable cutting tip of the harmonic curved shears broke during a robotic-assisted laparoscopic radical prostatectomy with preservation of the vascular bundles on both sides performed by the surgeon.

5
Device Type: da Vinci, Scissors, Curved
Device Identifiers: Catalog# P/N 400178; Lot# 140205187
Event Description: A patient was in the operating room for a robotic prostatectomy. The physician went to use the scissor instrument and noted that one of the blades was missing. Upon exploring the abdomen, the physician successfully retrieved the broken blade of the scissor. The event was reported to Intuitive Surgical, Inc., because the curved scissor is a new instrument in their inventory. The scissors that broke today had been used only once, the day before.

6
Device Type: da Vinci, Grasper, ProGrasp Forceps
Device Identifiers: Catalog# 400093
Event Description: At the end of a laparoscopic radical prostatectomy with robotic assistance, it was noted that the coating had rubbed off the ProGrasp instrument. The patient's abdomen was irrigated thoroughly, and no noted particles remained. Staff are aware that the coating can rub off from continual friction because of the positioning of the instrument. Because of draping, the field is hard to visualize. The da Vinci surgical team was made aware of the potential for this problem and will monitor the instruments while in use. Note that the ProGrasp instrument is tracked on number of uses. It was not documented as to how many times out of 10 this particular ProGrasp had been used at the time of this event.

7
Device Type: da Vinci, Grasper, ProGrasp Forceps
Device Identifiers: Catalog# 400093
Event Description: During the robotic-assisted dissection of the prostate, one of the grasping ProGrasp Forceps broke at the point where the specialized jaw end of the instrument is hinged to the shaft. There were three small fragments of black-colored material noted intraperitoneally, and these were retrieved uneventfully. This was the fifth use out of 10. The manufacturer was notified regarding this failure, and we are retaining the device in the event the manufacturer requests to evaluate it. We have not experienced any similar problems with this particular instrument.

8
Device Type: da Vinci, Grasper, ProGrasp Forcep
Device Identifiers: Lot# 1408061 05 Ver06
Event Description: During a procedure, the EndoWrist ProGrasp instrument broke while engaged and holding the fibroid attached to the patient's uterus. Laparoscopic observation revealed that one piece of the instrument had broken off. The piece was recovered laparoscopically and removed. As the instrument was being removed from the patient's abdominal cavity, additional pieces of the instrument broke off. The procedure was converted to an open procedure.

9
Device Type: da Vinci, Grasper, ProGrasp Forceps, 8mm
Device Identifiers: Lot# 1103051
Event Description: A patient was in the operating room undergoing a robotic laparoscopic hysterectomy when the tip of the ProGrasp broke while in the patient. It was noted that a small plastic piece was missing; it could not be determined, however, if the missing piece was in the patient, and it could not be detected by X-ray.

10
Device Type: da Vinci, Bipolar Cautery, Maryland Bipolar Forceps
Device Identifiers: Catalog# 420172
Event Description: While in a patient's abdomen, the Maryland bipolar forceps appeared to have shavings or particulate material on it. Whether these shavings entered the patient is unknown.

11
Device Type: da Vinci, Monopolar Cautery, Permanent Cautery Hook
Device Identifiers: Catalog# 4001833; Lot# 0706051-14 ver.01
Event Description: The instrument malfunctioned and was removed from the patient. Closer inspection showed that the working end of the instrument was frayed, and spiderweb cracks were noted on the shaft. Two or three pieces of plastic material were manually removed from the patient's abdomen by the surgeon, and more pieces were found inside the laparoscopic trocar.

12
Device Type: Monopolar Cautery, Permanent Cautery Hook, 7mm
Device Identifiers: Lot# 230T021/40 ver .02
Event Description: During a da Vinci assisted laparoscopic cholecystectomy, the tip of the da Vinci 7 mm hook cautery came apart. Three separate plastic pieces were identified and withdrawn from the surgical field.

13
Device Type: da Vinci, Monopolar Cautery, Permanent Cautery Spatula
Device Identifiers: Catalog# 400184; Lot# 91105107
Event Description: After the second robotic surgery of the day, the sterile processing staff determined that a wire was broken and a piece of the device was missing.

14
Device Type: da Vinci, Needle Holder, Needle Driver
Device Identifiers: Catalog# 400117; Lot# 131205130 Version 09
Event Description: A robotic 5 mm needle driver was being used to suture. The instrument was holding a 2/0 silk and was being used to tie a knot when one side of the needle driver tip broke off. The piece was easily visualized and retrieved.

15
Device Type: da Vinci, Needle
Device Identifiers: Lot# 0412061-018
Event Description: The patient was in the operating room suite undergoing a robotic-assisted laparoscopic radical prostatectomy. The large needle driver broke during the procedure, and a small piece of the tip was left in the patient, according to the surgeon.

16
Device Type: da Vinci
Event Description: The patient was to undergo laparoscopic lysis of adhesions and retropubic radical prostatectomy utilizing robotic assistance. At beginning of the procedure, there was a malfunction on the second robotic arm. One of the plastic wings used to tighten down the arm broke off while the surgeon was attaching the second arm to the cannula. The robotic sensors would not allow the tool to be used. At this point, a company representative was called, and alternatives were discussed. (This was not a repairable piece of the robot during this surgery.) The surgeon was able to get the second arm functional, and it seemed to work, but as soon as one tool was changed out for another, the arm became nonfunctional again. The robot was undocked, and all the ports were closed in the usual fashion. The patient was prepped again, redraped, and underwent an open radial prostatectomy. The day after the event, the service representative from Intuitive Surgical, Inc., came to the site and installed a new mount (broken cannula mount) on the patient-side manipulator 2 and tested the system, and the system passed all tests.

17
Device Type: da Vinci
Event Description: During a cardiac robotic surgical procedure using a da Vinci surgical system, the robot's third instrument arm (ARM4) stopped functioning. The surgeon removed the instrument from the affected arm and placed it on ARM1, after which the instrument tested okay. The surgeon then tried unsuccessfully to reattach the instrument to ARM4 three different times, as instructed by the manufacturer's clinical representative, who was present during this surgical procedure. The surgeon had to make another incision in the patient to attach an atrium retraction instrument to complete the procedure. The manufacturer’s representative finally placed ARM4 in the complete STOW position and redeployed the arm to a cold reboot status. After the reboot of ARM4, the system was then able to detect the instrument, and the surgeon completed the case without having to use the additional incision site and without further robotic system failure.

18
Device Type: da Vinci S
Event Description: A physician was performing a laparoscopic radical prostatectomy with robotic assistance when a fault occurred with one of the instrument arms. Despite several attempts at restarting the system, and in telephone contact with the company, the system fault could not be overridden, and the procedure could not go further in its current status. The robot was then moved away from the patient, and the procedure was converted to an open radical prostatectomy. Analysis of the device identified a "third arm fault." Error code 25504 was identified, which basically indicated there was a "mismatch" code, meaning that there is a problem with the arm’s lining up perfectly. Mismatch can occur for a variety of reasons, from part failure to a dirty sensor. It was determined that the patient-side manipulator (PSM) was suspect. The service representative ordered and installed a new PSM and tested the system; the system passed all tests. The removed part was sent to the home office for analysis.

19
Device Type: da Vinci, Reusable System Accessory, Cannula Holder, Twist-Lock
Device Identifiers: Catalog# 370946-02
Event Description: A surgeon was performing a robotic-assisted total abdominal hysterectomy/bilateral salpingo-oophorectomy, when he began having trouble with the robotic third arm. A surgery technician discovered that the cannula holder had broken.

20
Device Type: da Vinci
Event Description: During a procedure employing the robotic surgical system to treat atrial fibrillation via radiofrequency ablation of ectopic foci, intraoperative bleeding was experienced that required initiation of a cardiopulmonary bypass. The bleeding of the atrial wall was caused by the AtriCure ablation electrode (Isolator Transpolar pen), which had been unhooked from the robotic arm and was being manipulated manually. The cardiopulmonary bypass was initiated to rectify and complete the procedure. Secondary complications included a stroke and aortic dissection.

21
Device Type: da Vinci
Device Identifiers: Model# SS2000
Event Description: The event occurred during a robotic thymectomy. The surgeon was operating with the robot, and we lost power to the robot. We unplugged and replugged in the tower until it repowered. The robot was reactivated, and surgery continued. The sales representative discovered that a plug to the da Vinci robot had been changed and placed in one of the power strips, which caused too much power to be drawn. The light source was to have its own outlet. The Biomedical Department corrected the problem by getting us a new cord, which was replaced after the procedure.

22
Device Type: Robotic Laparoscope Holder
Event Description: When the Bovie is in use, the Aesop command conflicts with the microphone connected and microphone disconnected, making the Aesop inoperable. There were two such incidents. The Biomedical Department assessment is that there is a possible interference between Valleylab ESU units and the Aesop units. The recommendation is that the operating room staff use only a certain ESU. When using Aesop units, this particular ESU does not seem to cause the problem. All three Aesop units have had related issues. The Biomedical Department is also following up with the manufacturer to determine if their representatives are aware of the problem.

23
Device Type: da Vinci
Event Description: During a procedure to repair the mitral valve regurgitation using the da Vinci robotic surgical system, the aortic valve leaflet was perforated during placement of the cardioplegia catheter. This necessitated initiation of a cardiopulmonary bypass to repair the leaflet and complete the procedure. Upon removal from the bypass, the patient entered cardiogenic shock brought about by biventricular failure. Additionally, the patient went into renal failure. The patient remains hospitalized with partial recovery of left ventricular function.

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Updated November 1, 2007

Return to MedSun: Medical Product Safety Network

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