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U.S. Department of Health and Human Services

MedSun: Newsletter #24, May 2008

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Newsletter #24, May 2008

Articles

Important Notice to Manufacturers and Initial Distributors of Medical Devices That May Contain Heparin Or Are Heparin-Coated

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The recent serious injuries and deaths associated with the use of potentially contaminated heparin are very much in focus at this time. To the MedSun Community: Your reports submitted to MedSun are key to MedSun's success in helping FDA and the manufacturers ensure the safety of medical devices, tissues, cells, and related products, so please report the problems you see. The information from incoming reports shared through MedSun News and the de-identified versions of the reports contributed to FDA’s public database benefit health care facilities and researchers throughout the Nation. You may still report these heparin issues though the MedSun system and rest assure they will be directed to the attention of the Center for Drug Evaluation and Research (CDER).

Additional Information:

Important Notice to Manufacturers and Initial Distributors of Medical Devices That May Contain Heparin Or Are Heparin-Coated. FDA Website. April 8, 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm135345.htm

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FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries

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FDA Press Release

U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach announced that the agency has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries.

Over the past few years, FDA and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation. The draft guidelines issued today—called an FDA guidance document—outline the agency's recommendations for pre-market clinical evaluation and post-market studies, which may provide data to better address this and other potential safety concerns.

Each year in the United States, approximately one million patients undergo procedures to treat coronary atherosclerosis, also known as hardening or blockages of the heart arteries, a condition that can cause angina and heart attacks.

Some 650,000 of these patients are treated with drug-eluting stents, a scaffolding device that is placed into the arteries to prop them open. Drug-eluting stents have a coating that slowly releases a drug to prevent the growth of scar tissue that may accumulate after the initial procedure opens the artery. Re-accumulation of scar tissue can mean additional procedures to keep arteries open and preserve adequate blood flow.

"This draft guidance is part of FDA's ongoing effort to provide regulated industry with recommendations on measures that can minimize the risks while preserving for patients the benefits of drug-eluting stents," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

This draft guidance, announced in the Federal Register, http://www.gpoaccess.gov/fr/index.html, discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for a complete marketing submission. It also provides guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. Because these stents combine device and drug technology, this guidance contains expertise and input from two agency centers—the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.

Also included are draft recommendations for engineering tests, biocompatibility tests, and animal studies to assess the device's overall safety.

"This guidance demonstrates how FDA will need to work across traditional product boundaries to guide the development of innovative new products," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

Currently, FDA has approved three coronary drug-eluting stents.

FDA is planning a public workshop on drug-eluting stents, in part as one means of soliciting comments on this guidance. The date, location and method for comment for this workshop will be announced in the Federal Register and on FDA's Web site, www.fda.gov.

FDA invites public comment on this draft guidance for 120 days from today's publication in the Federal Register.
Typed comments should include the docket number (CD6255), and be sent to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

To submit comments via the Internet, go to:
http://www.regulations.gov/search/index.jsp
Type in the docket number (CD6255), and follow instructions for comment submission.

Additional Information:

FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries. FDA Press Release. March 26, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116871.htm

The Federal Register (FR) Main Page is available at:
http://www.gpoaccess.gov/fr/index.html

To submit comments via the Internet, type in the docket number CD6255 at:
http://www.regulations.gov/search/index.jsp

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Preventing Accidents and Injuries in the MRI Suite

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© The Joint Commission, 2008.

While the capabilities of the MRI scanner are well-recognized, its inherent dangers may not be as well known. Injuries and deaths can and have occurred in the MRI suite. The article provides risk reduction strategies and Joint Commission recommendations to reduce MRI accidents.

Additional Information:

Preventing Accidents and Injuries in the MRI Suite. The Joint Commission. Issue 13. February 14, 2008.
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_38.htm

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Alarm Interventions during Medical Telemetry Monitoring: A Failure Mode & Effects Analysis

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Pennsylvania Patient Safety Authority

Summary: Between June 2004 and October 2006, PA-PSRS received 277 reports related to alarm response during medical telemetry monitoring. All of the reports described events in which patients were not consistently monitored for physiologic conditions, and three events resulted in patient death. PA-PSRS analysts conducted a failure mode and effects analysis (FMEA) on alarm interventions during medical telemetry because of the potential for serious patient harm or death. Healthcare facilities can use the published results of this FMEA to understand telemetry monitoring alarm response processes and similar process failures and as an aid to develop facility-specific risk reduction strategies.

Additional Information:

Alarm Interventions during Medical Telemetry Monitoring: A Failure Mode & Effects Analysis. Pennsylvania Patient Safety Authority. March 2008.

http://www.psa.state.pa.us/psa/lib/psa/advisories/v5n1march_2008/mar_2008_medical_telemetry_fmea_supplementary_review.pdf

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Preventing the Retention of Foreign Objects during Interventional Radiology Procedures

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Pennsylvania Patient Safety Authority

The article provides recommendations and safe practices to help prevent the retention of foreign objects during interventional radiology (IR) procedures. Facilities policies should routinely include the use of sponge, sharp and instrument counts in IR to prevent the risk of serious patient harm related to the retention of foreign objects in this setting.

Additional Information:

Preventing the Retention of Foreign Objects during Interventional Radiology Procedures. Pennsylvania Patient Safety Authority. March 2008.

http://www.psa.state.pa.us/psa/lib/psa/advisories/v5n1march_2008/mar_2008_v5_n1_article_foreign_objects_interventional_radiology.pdf

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HeartNet

Of Special Interest to Electrophysiology and Cath Lab Staff/HeartNet

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Low Frequency Magnetic Emissions and Resulting Induced Voltages in a Pacemaker by iPod Portable Music Players

By Howard Bassen (FDA)
BioMedical Engineering OnLine. February 2008, Volume 7.

Abstract

Background
Recently, malfunctioning of a cardiac pacemaker electromagnetic, caused by electromagnetic interference (EMI) by fields emitted by personal portable music players was highly publicized around the world. A clinical study of one patient was performed and two types of interference were observed when the clinicians placed a pacemaker programming head and an iPod were placed adjacent to the patient's implanted pacemaker. The authors concluded that "Warning labels may be needed to avoid close contact between pacemakers and iPods". We performed an in-vitro study to evaluate these claims of EMI and present our findings of no-effects" in this paper.

Methods
We performed in-vitro evaluations of the low frequency magnetic field emissions from various models of the Apple Inc. iPod music player. We measured magnetic field emissions with a 3-coil sensor (diameter of 3.5 cm) placed within 1 cm of the surface of the player. Highly localized fields were observed (only existing in a one square cm area). We also measured the voltages induced inside an 'instrumented-can' pacemaker with two standard unipolar leads. Each iPod was placed in the air, 2.7 cm above the pacemaker case. The pacemaker case and leads were placed in a saline filled torso simulator per pacemaker electromagnetic compatibility standard ANSI/AAMI PC69:2000. Voltages inside the can were measured.

Results
Emissions were strongest (˜ 0.2 µT pp) near a few localized points on the cases of the two iPods with hard drives. Emissions consisted of 100 kHz sinusoidal signal with lower frequency (20 msec wide) pulsed amplitude modulation. Voltages induced in the iPods were below the noise level of our instruments (0.5 mV pp in the 0 – 1 kHz band or 2 mV pp in the 0 – 5 MHz bandwidth.

Conclusion
Our measurements of the magnitude and the spatial distribution of low frequency magnetic flux density emissions by 4 different models of iPod portable music players. Levels of less than 0.2 µT exist very close (1 cm) from the case. The measured voltages induced inside an 'instrumented-can' pacemaker were below the noise level of our instruments. Based on the observations of our in-vitro study we conclude that no interference effects can occur in pacemakers exposed to the iPod devices we tested.

Additional Information:

Low Frequency Magnetic Emissions and Resulting Induced Voltages in a Pacemaker by iPod Portable Music Players. Bassen, Howard. BioMedical Engineering OnLine. February 2008, Volume 7.

http://www.biomedical-engineering-online.com/content/7/1/7

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LabNet

Of Special Interest to Laboratorians/LabNet

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FDA's Office of In Vitro Diagnostics has approved the following new devices for marketing:

Dako TOP2A FISH pharmDx Kit is a laboratory test used to help a doctor assess the likely clinical course for certain patients with breast cancer. The test uses fluorescent DNA probes to measure the number of copies of the TOP2A (Topoisomerase 2 alpha) gene on chromosome 17 in breast cancer cells. The TOP2A gene plays a role in cell division. Changes in the number of copies of TOP2A gene indicate an elevated risk of post-surgical recurrence of the breast cancer or decreased long term survival.

FreeStyle Navigator Continuous Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and over, with diabetes.

_____________________________

To see additional In Vitro Diagnostic Devices recently cleared for marketing visit:
http://www.fda.gov/cdrh/oivd/

Click under the left hand column "Quick Links" on the link "New OIVD products"

_____________________________

FDA's Office of In Vitro Diagnostics Device Recalls, a searchable database of devices recently recalled by FDA's Office of In Vitro Diagnostics can be found at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/IVDRes.cfm

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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 February 1 through February 29. 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.


CARDIOVASCULAR

Device: Monitor, Physiological
Model# DASH 4000
Manufacturer: GE Medical Systems Information Technologies
Problem: GE DASH 4000 display spontaneously going blank or blacking out while in use on NICU patients. The displays remain off despite multiple attempts by clinicians / RNs to reboot the system. Clinicians / RNs unable to view ECG tracings and other hemodynamics on NICU patients.
======================
Manufacturer response for Monitor, DASH 4000
======================
GE has identified that the displays inverter is the cause of the problem. GE has sent replacement inverters for all the DASH 4000s in the NICU. We will be sending GE the problematic inverters for evaluation. GE provided loaner DASH 4000s during this timeframe

(Note from FDA: A similar report has been submitted from the same facility describing issues with a new inverter).

Device: Pacemaker; Sensia
Manufacturer: Medtronic, Inc.
Device: Lead, Pacemaker, Atrial
Model# 4076
Other device# 45 cm
Manufacturer: Medtronic, Inc.
Device: Lead, Pacemaker, Ventricle
Model# 5076
Other device# 52 cm
Manufacturer: Medtronic, Inc.

Problem: Patient had a permanent dual chamber pacemaker implanted by physician with the manufacturer rep in attendance for a hypersensitive carotid. At the end of the case and the following day there was a check of the device which looks at its function. Follow up visits to the physician's office in one month and then at 3 months demonstrated some 'high' impedance issues. It was thought that it was perhaps a lead dislodgement. Patient came in 3 months after the pacemaker implantation for a 'lead revision.' When the manufacturer's rep checked the device before the procedure, it was found that the A lead was in the V insertion and the V lead was in the A position. The procedure involved opening the pocket and switching the leads to the right orientation in the generator. Patient was discharged 4 hours later. In follow up with both the physician and the manufacturer the chart was reviewed and the strips which are run during the pacer check (done immediately after the procedure and a month later) showed the problem was evident. It had not been communicated to the physician and physician does not routinely look at the strips. Manufacturer has looked at their process, and is adding some features to their paperwork including reading of the #'s on the leads, which apparently the physician did not do at this time, and assuring it is done or crossed through if the physician refuses to do the check by reading the numbers. The physician could look over the strips as well.

(Note from FDA: Good example of Human Factors issues seen with medical devices).

Device: Kit, Pressure Monitoring; Arterial Line Kit with Transducer; Medex LogiCal
Lot# 1147063
Other device# V-link V2847
Manufacturer: Smiths Medical
Problem: During a dressing change, blood was observed backing up in arterial line pressure tubing. The tubing was fractured at the manifold. Approximately 20 ml of blood was lost. This is the sixth occurrence of this nature in our facility.


RADIOLOGY

Device: Cardiovascular System, X-ray; Allura Xper FD10/10
Other Device# Control panel: Allura FD/10
Manufacturer: Philips Medical Systems
Problem: This event occurred during patient transfer from the gurney to the Philips Allura Xper FD10/10 biplane procedure surface, using a left side approach. The left side must be utilized for patient transfers, as additional equipment is adjacent to the right side of the table. The detachable control panel (which looks like a keyboard), is responsible for controlling the X-ray table, the C-arm, etc., and is usually located on the left. However, in order to transfer this patient, the control panel had been detached and moved to the end of the table. The patient inadvertently hit the control panel with his foot and activated the C-arm, which swung down and almost hit him in the head. The control panel does not have a locking mechanism, or any way to prevent accidental contact with the toggle switches. The risk manager and biomedical engineers were easily able to replicate inadvertent action of the device. Alternative control panel locations were discussed, but it was concluded that no matter where it is located, the potential for inadvertent activation is present. Therefore, the risk of harm to patients and staff members remains a significant issue.

Currently, the control panel is being removed from the rail, (which requires removal of the lead protective radiation shield) and relocated to an area away from action. However, it is still not completely "safe" from unintentional activation, as it is possible for the buttons/switches to still be "bumped". If Philips could make any of the following modifications, i.e.: install a protective guard on the control panel, devise a control panel lock-out switch, or incorporate a separate C-arm "brake" button, events like this could be prevented. We notified the vendor representative, but they did not get any indication that Philips would be implementing any sort of locking option or other protective mechanism.

(Note from FDA: Good example of Human Factors issues seen with medical devices).

Device: Computed Radiography System; Fuji Smart CR
Model# CR-1R346RU
Manufacturer: Fujifilm Medical Systems
Problem: The CR reader located in the Inpatient Viewing area will periodically not process the imaging for the CR plate that is being processed. When this occurs, a clear image displays and a broken communication error message appears with a reset button. Upon pressing the reset button, which has to be pressed in order to proceed, an image displays. However, the image that appears is not the correct image belonging to the patient; it was the previously processed image from the previous patient. This is an intermittent problem that may cause patients to receive unnecessary treatment, or may cause treatment needed to be missed. The CR reader was place out of service until further testing resolves the above issues. I was actually able to talk to the Fuji rep. There have not been any recent software upgrades or updates nor do they have any upgrades that need to be installed. The rep and our Imaging Services have identified the problem. There was a duplicate IP address within the hospital and when there was a conflict, the connection would drop off the network and momentarily lose connection and that is what caused the CR to display an image from the previous patient. Imaging services has received another IP address and the problem has been resolved.


ANESTHESIOLOGY

Device: Anesthesia Machine; Aisys Carestation
Manufacturer: GE Medical Systems, LLC
Problem: Biomed was paged regarding a leak on the anesthesia machine in the OR. This machine was a brand new machine just put into service. Upon arrival in room, noticed the desired tidal volume(TV) was not equal to the Tvexp (there was a sizable leak of about 450mL). Biomed performed the preliminary checks. The flow sensor module was swapped but there was no effect. It was inspected but there was no sign of moisture or physical damage. GE Clinical Application Specialist arrived to help. Removed EZ change and condenser from system to see if this was cause of leak, but no effect. Noticed bellows was driving all the way, with no apparent leak. Application specialist asked user if they could switch to PCV-VG and SIMV. The FiO2 (previously low 90s), increased to mid-high 90s. But user still uneasy with anesthesia machine telling them there was a leak. However since biomed was unable to troubleshoot further while machine was being used on a patient, and patient vitals were stable and SpO2 sat high, user agreed to continue the case. After the case the machine was pulled out of service for further investigation. The next day GE field service engineer troubleshot and tested machine. Logs downloaded and sent to GE Engineering for analysis. Nothing out of the ordinary was found in the logs. Field service engineer found 2 faulty flow sensors reading erratically. Replaced flow sensors. Machine tested according to manufacturer
======================
Manufacturer response for Anesthesia Machine, Aisys Carestation
======================
Sent field service engineer to test and troubleshoot. Replaced faulty flow sensors. Analyzed logs and reported nothing out of the ordinary.

Device: Tray, Spinal; Portex 25 Gauge Whitacre
Lot # 1242942
Catalog# 15545C-20
Other device# Bupivacaine HCl 0.75% in Dextrose inj 2ml
Manufacturer: Smith's Medical ASD, Inc.
Problem: Anesthesiologist injected patient with Bupivacaine HCl 0.75% in Dextrose 8.25%. Sensory effect was achieved, but not motor effect. Anesthesiologist states that this is the third such case in the past month or so.

Device: Flowmeter, Wall, O2; Western Medica Flow-Meters
Lot# FME0403
Catalog# FME107
Manufacturer: Western Medica
Problem: Event describes noses separating from quick connectors while the quick connect remained in the wall outlet. Quick connects on flowmeters are defective, noses are falling out and flowmeters are falling off the wall.

Analysis: Following a phone conversation with the user facility, it was learned that one of the failed quick connectors was from a flowmeter. The serial number was in the following format: "FMxYYMM-", where "YY" represents the year and "MM" the month of manufacture. Over a period of 6 years, Western manufactured Ohmeda quick connectors with noses made of brass. Over that period, Western has received reports of failures involving noses separating from the body of the connector. Although the nose to body press fit connection was deemed adequate for the expected application, the various forces and pressures exerted on the connector under certain conditions could weaken the connection over time, and result in separation of the nose from the connector body. The number of pieces involved in nose separation failures over that period represented 0.131% of product produced. Quality Department Quantity: 15

Corrective Actions: A formal engineering investigation was initiated to investigate this mode of failure. Following engineering lab and production testing, it was determined that changing the nose material from brass to stainless steel significantly improves the retention of the nose in the connector body. An engineering change was initiated and the nose material was changed from brass to stainless steel. The change was implemented approximately 3 years ago.

The unit being returned will be evaluated and the old version quick connects were replaced with current version quick connects at no charge. Western will continue to monitor product return data for the purposes of trend identification, potential improvements, corrective actions and/or countermeasures.


GASTROENTEROLOGY/UROLOGY

Device: Monitor, Esophageal PH; Bravo
Model# 7126
Lot# 0211286
Manufacturer: Medtronic Gastroenterology/Urology
Problem: Bravo Capsule did not release from deployment device. The patient was given instructions to remain on clear liquids for 36 hours and then progress to a soft diet. This is due to a superficial esophageal tear that occurred while trying to deploy the device. The patient was released without complaints or problems.
======================
Manufacturer response for Monitor, Esophageal pH, Bravo
======================
Referred us to device Recall Letter dated December 2007.

Device: Dialysis Machine, CRRT; Diapact
Model# 2.10.1
Manufacturer: B. Braun Medical, Inc
Problem: The Diapact CRRT did not alarm, but was pulling air through the PA pressure sensor, which is located inside the machine, and air was entering the blood tubing. There were no outside leaks or cracks. They had to clamp the pressure line every minute or so to prevent the air entering the blood stream. Pressure readings were negative and believable.
======================
Manufacturer response for CRRT, Diapact
======================
It was caused by a cracked PA connector that could not be seen by nursing. Left connectors and trained inhouse staff about changing them

Device: Feeding tube; Transgastric Enteral Tube
Catalog# 20125
Manufacturer: Moss Tubes, Inc.
Problem: Family reports observing RN's inject into balloon port. When tube was inspected, it was found to have a burst balloon. This may have led to tube malposition and associated problems. Tube (outside of body) looks very similar to non-balloon feeding tube with side med/flush port. Balloon port only labeled "H20 20cc". Several experienced nurses state this could easily be understood as "flush with 20cc of water."

(Note from FDA: Good example of Human Factors issues seen with medical devices).

Device: Reprocessed Ethicon Trocar; Xcel Blunt Tip
Lot# 149680, 149764, and “unknown”
Catalog# H12LP
Manufacturer: Ascent Healthcare Solutions
Problem: A total of 5 reprocessed trocars broke apart during use. One was from lot number 149680, three were from lot number 149764, and one was from an unknown lot number. The five broken trocars were sent to the manufacturer (reprocessor) for analysis. The reprocessor's analysis indicated that, based on their findings, a change would be made in the disassembly procedure involved in reprocessing this trocar. According to the reprocessor, "This modification will assist in mitigating future occurrences of this nature."


PHYSICAL MEDICINE

Device: Air Transfer Mattress; HoverMatt
Model# HM34HS
Other device# Cannister - Model GSPJ115
Manufacturer: HoverTech International
Problem: Bariatric patient with multiple trauma was being transferred from cart to procedure table and back again multiple times one morning with use of a hover mattress. Transfers were without incident until staff (5) were transferring patient from the cart back to the patient's bariatric bed. The hover mattress was inflated with the cart positioned next to the patient's bed with cart brakes on. The bed had been lowered two inches to enable sliding of the hover mattress with the patient on to the bed. During the transport, the hover mattress tilted toward the patient and the hover mattress and patient slid between the cart and the bed. The patient landed on the floor. The patient was awake and moved all extremities and shook head "no" to pain in neck/back. Patient's trach and drains were secure. CT scans of head, neck, spine, chest, abdomen, pelvis were ordered immediately with negative results.

Follow-up reveals that the members of the lift team report that one of the issues they have seen is that the hover mat will not uniformly inflate, depending on the weight of the patient. Usually, the heavier the patient, the more of a problem with uniform inflation. This may indicate why the hover mat tilted in this particular case. They have seen this before, but in other cases, this did not result in a patient falling to the floor. They have not seen any other issues regarding using a cart to bed transfer, or bed to cart, and it doesn't seem to matter if the bed is bariatric or not.


GENERAL HOSPITAL

Device: Pump, IV; Symbiq
Manufacturer: Hospira Global Medical Affairs
Problem: Levophed was being infused via a Symbiq pump to a patient. The patient required Levophed at titrated dosages to keep his/her blood pressure stable. The Symbiq pump failed and the malfunction code of S321 was displayed. The patient's blood pressure dropped significantly and the pump was pulled from service. A new pump was obtained and the Levophed infusion was resumed. The patient's blood pressure was stabilized. The cause of the failure was found to be a defective motor. The pump will be sent for factory repair because motor replacement can not be done in the field.
======================
Manufacturer response for Infusion Pump, Symbiq
======================
Malfunction log indicated code S321 and the unit's motor was replaced.

Device: Pump, IV, Module; Medley LVP
Other device# EEU0740
Manufacturer: Alaris Medical Systems, Inc.
Problem: Initially Alaris pump screen showed Heparin infusion at 5 ml/hour with appropriate drip chamber flow. Nurse noted drip chamber started to free flow without pump beeping and screen still reading 5 ml/ hour. Patient received approximately 5,000 unit bolus of heparin (50 ml). Infusion stopped and pump removed from service. Patient without apparent injury. Follow-up indicates that the pump had passed the occluder testing just prior to the event, and subsequently failed the test when the pump was tested after the event. The pump has since been sent back to the company for corrective action.

The hospital has a total of 1,114 Alaris Large Volume Pump modules which are managed and serviced for the hospital by a third party distributor. The pump distributor has completed occluder testing of 1046 of the LVP modules, as of this date, using the latest protocol provided by Alaris. Pumps which fail the occluder testing are returned the the distributor's District Office where the failure is verified, and failed pumps are then returned to Alaris for X-ray inspection. Of the 1046 pumps which have been tested, 80 LVPs have failed the occluder test, or 7.65%.

Device: Tubing, IV
Model# FB1L03
Lot# 1247292
Manufacturer: Smiths Medical MD, Inc.
Problem: Over the past month or two we have had two separate types of problems with Medex IV tubing. I have already submitted a report on the first problem (ball in drip chamber not sealing at the opening, so that air enters the line) but it is still happening sporadically despite changing lots. The second problem is leaking of the sets. This has also occurred several times; once where the tubing connects to the drip chamber and at least twice where the tubing connects to the pumping mechanism. These incidents have all happened on different patients. The manufacturer is aware of these problems. We do not have the tubing available as they contained chemotherapy.

Device: Pump, IV; Alaris PC
Model# 8015
Manufacturer: ALARIS Medical Systems, Inc.
Problem: The pump stopped infusing and read "System Error". The biomedical assessment revealed that the pump's error log had one error code: 111.200.0. This is a known software problem which Alaris fixes by re-flashing the pump's software. At this time, Alaris does not know the cause of this particular problem. The pump will be sent to Alaris for evaluation and repair. There was no patient harm as a result of this failure.

Device: Catheter, PICC; V-Cath
Lot# 4Fr 1026, 1029, 1030; 5Fr 1033
Catalog# 4Fr: 4029-1660; 5Fr: 5029-2660
Manufacturer: HDC Corp.

Device: Dilator; Coaxial Dilator Micro-Introducer
Manufacturer: Enpath Medical, Inc.

Problem: There have been multiple problems with the introducer kits that require the Seldinger technique. They fall into three groups:
1) Leading edge of Peel-away introducer is flared which would likely cause injury if pushed into a vein (have seen twice).
No response yet

2) Tip of dilator won't allow guidewire to pass. (This has happened around four times to several IV nurses, but visual inspection of kits reveals a non-circular opening in about 15% of dilators.) This results in a complete redo of insertion which can be difficult on some patients.
Problematic dilators come from a company called Enpath. HDC has sent dilators from a different company. They function the same way. Reportedly, HDC doesn't manufacture the dilators. They buy them from third parties: Enpath and others. The Enpath dilators were the ones that were having the problems. Another company's were offered as replacements so that the existing kits could still be used. They come in individual sterile packs.
3) Handle on end of guidewire came off so that wire could not be removed properly (occurred once). This required a second insertion through the existing introducer.).

Device: Pump, Implantable, Pain Relief; On-Q PainBuster
Other device Ref #PM023-A
Manufacturer: I-Flow Corporation
Problem: A patient with Hirschsprung's disease, who a year and a half ago, underwent an abdominal perineal resection. He had a non-healing wound for about a year until he underwent closure of two perineal fistulas. During the procedure, while under fluoroscopy, a radiopaque linear density was noted. The area was probed, and a retained foreign object was removed, which turned out to be a piece of the split introducer from the I-Flow ON-Q Painbuster.

According to the manufacturer's representative; this issue has been sent onto the corporate office and a reply has been requested with any information on advancements in product manufacturing that will help prevent this from occuring.

Possibility of including markings or color coding on the sheaths (similar to that on the catheters), leads to the question of what to do if the sheath does peel unevenly and how to remove the sheath at that point?

A suggestion for prevention of this occurance is to slide the sheath back out over the catheter until it is entirely removed from the pt and then peel the sheath apart. Similar to what they currently do, they may need to steady the catheter as they pull pack on the sheath to prevent the catheter from sliding back out.

Device: Tubing, IV, PCA; Gemstar
Lot# 61-180-5H
Catalog# 19559-01
Manufacturer: Hospira Global Medical Affairs
Problem: The patient awoke at home in the morning, and noticed the pump tubing was wet near the filter. She called the clinic and was instructed to stop the pump, wash her skin in case she came into contact with the chemotherapy, and to return to the clinic.

This is the fourth report we have submitted regarding problems with this tubing leaking. The first three reports were submitted one month ago. The lot # for the previous reports was 571635H. The lot # for this report is 611805H. According to clinic staff, additional incidents have occurred since, but I do not have that information at this time. It seems the issues involve leaking around the filter.

Device: Hypothermic Device, Head; Olympic Cool-Cap
Manufacturer: Olympic Medical Corporation, a Natus Company
Problem: Term female baby admitted to NICU on 02/15/08 for perinatal asphyxia. Baby met criteria and placed on Olympic head cooling system. Approximately thirty minutes after cooling was initiated, the specialist reported that the cap temperature was not responding to settings and the cap temperature continued to fall despite increases the cap temperature. Cap reading was consistently between 5.2 and 5.5 (manufacturer recommends cap no lower than 8 degrees). A warmer was used to maintain appropriate rectal and fontanel temperatures. Also, orders were placed to check the baby’s scalp every four hours (manufacturer recommends every 12 hours) and the baby was repositioned every two hours. A telephone call was placed to Olympic technical support line. After several hours it was determined that there was a power supply issue that prohibited the machine from responding to the message from the software to increase cap temperature. Possible risks for continuing to use the cap were discussed with technical support; however given the baby’s condition a medical decision, with consent from the family, was made to continue with the therapy. No other complications were noted during the duration of the treatment.

Device: Catheter, PICC; VAXCEL-PASV PICC/5/2
Model# MOO1454700
Lot# 1224626 and 1232872
Manufacturer: Boston Scientific Corp.
Problem: Seven PICC lines have been identified as apparently defective as patients have returned due to leaking. Found all have a crack in leg of catheter. Removed and replaced with new line.


LABORATORY/DIAGNOSTIC TESTS

Device: Needle, Safety; Vacutainer Eclipse Blood Collection Needle
Lot# 7290975
Catalog# 368607
Manufacturer: Becton Dickinson
Problem: The safety device on the BD Vacutainer Eclipse Blood Collection needle did not work properly. The safety device popped off and the employee was stuck while trying to activate the device. This is the third incident involving this type of device, and there have been many "near misses". The cover of the device flips up, but does not completely cover the needle, or else it slips to the left or right of the needle. Additionally, the caps have been known to break off. The manufacturer's response when they were notified of this failure was: There are a number of reasons which could affect the shield popping-off on the BD Eclipse Blood Collection Needle. In many instances, there is a combination of factors at work, i.e. manufacturing issues, storage issues, and handling issues. It is difficult to rule out any of these when dealing with the shield on the Eclipse needles.

Device: Kit, Urine Pregnancy Test; Fisher Sure-Vue Serum/Urine HCG-Stat
Lot# 7090052
Manufacturer: Innovacon, Inc.

Device: Kit, Urine Pregnancy Test; Fisher Sure-Vue Serum/Urine HCG-Stat
Model# 7070191
Catalog# 23900530
Manufacturer: Innovacon, Inc.

Problem: False positive result obtained by health assistant performing qualitative urine hCG pregnancy test on patient using Fisher Sure-Vue Serum/Urine HCG-Stat kit lot hCG7090052. The test was repeated using same kit lot and the same positive result was obtained. A positive result was also obtained using kit lot hCG7070191. However, a negative result was obtained on the same specimen using kit lot hCG7070060. Patient was a postpartum patient who denied having intercourse since delivery approximately one month prior to event so it was expected that result would be negative. A blood specimen was drawn on the patient for a quantitative hCG test performed in the central laboratory which came back negative (<5 mIU/mL).


OPTHALAMIC

Device: Pack, Vitrectomy, Light Probe; Total Plus Pak with a 2500 Probe
Lot# 7028447X
Manufacturer: Alcon Laboratories, Inc.
Problem: Report from unit states: The fiberoptic light probe that comes in our 20 ga Total Plus Vitrectomy Pak began to char at the tip of the probe during the procedure. The surgeon withdrew the probe from the patient's eye. The probe was removed from the field and the packaging was collected for identification. The company, Alcon, was contacted and all packs with that lot number were sequestered awaiting word from the vendor. Doctor states that there was a burn on the tenons of the patient, which he states was not of great severity, but was evident to the eye.

Device: Phaco Emulsifier; Sovereign Compact Console Universal; White Star
Manufacturer: Advanced Medical Optics, Inc.
Problem: The unit with handpiece was primed and tuned before the procedure started. Everything checked out. During the procedure the unit had low power then stopped working. Staff did not want to proceed further. The patient sustained vitreous loss with lens drop. Doctor received a consult to send the patient to a specialist for the corrective procedure, which involved removal of lens material via a pars plana approach.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Transcatheter Septal Occluders

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The purpose of providing this summary, and the following reports, is to inform you about problems reported to FDA by the MedSun clinical community. These, as well as non-MedSun reported problems involving this device may also be investigated by searching FDA’s on-line MAUDE database. See Additional Information below.


Transcatheter septal occluders are devices delivered through a catheter and placed to close defects (holes) in the septum (walls) between the two atria or the two ventricles of the heart.
Over the past 2 years, MedSun has received 10 medical device adverse event reports involving transcatheter septal occluders associated with three manufacturers: AGA Medical (8), NMT Medical (1) and W.L. Gore and Associates, Inc. (1). The reports were submitted by 6 hospitals between April 1, 2006 and April 17, 2008. The most frequently reported device problems are (please note, several problems are often reported in one report):

•Problems preventing implant of the device requiring removal (7)
•Migration of the device (4)
•Difficulty removing the device (2)

There are no MedSun reports involving a patient death during this time period. The most frequently reported patient problems are (again, more than one problem is often reported per report):

•Need for an additional surgical procedure or prolonged surgery (7)
•Need for removal of foreign body (3)
•Required hospitalization related to the event (3)

Of the reports that list patient age, 1 report has a patient age listed as less than 21 years and no reports have a patient age listed as greater than 21 years. All 10 reports listed patient gender; 5 reports involve female patients and 5 reports involve male patients.

These MedSun reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.


MedSun Transcatheter Septal Occluder Adverse Event Reports received between April 1, 2006 and April 17, 2008
Device Device Identifiers Event Description
AGA MEDICAL CORPORATION/Amplatzer Catalog: 9-ASD-019 Lot: M05G25-2B/TD>Upon release of the Amplatzer device across the atrial septum it became mis-aligned and became "free floating" in the left atrium. Device was captured with a snare but unable to retrieve. Device secured in position. Patient
to OR for retrieval and repair.
AGA MEDICAL CORPORATION/AMPLATZER Lot: M03C20-25 Patient with Large Secundum ASD (Atrial Septal Defect) had insertion of Amplatzer occluder device over a year ago. Within the past year, he has recently been hospitalized twice. Late last year, presented with blurred vision of left eye associated with headaches which occurred in A.M. extensive Neurology, Cardiology and Opthomology work up demonstrated left temporal field defect with abnormal fundoscopic exam and evidence of small microemboli effecting small area of optic nerve. Hyper coag work-up was negative. He then presented one month later with left arm and leg paresis. He had magnetic resonance venogram (MRV), magnetic resonance angiogram (MRA) and transesophageal echocardiogram (TEE). TEE demonstrated a small residual ASD in the superior part of the device of the superior vena cava (SVC) end. No clots or vegetation. Neurology symptoms were thought to be transient ischemic attacks (TIAS). Based on findings, all MDs involved in care determined that best course of action would be to remove device and repair ASD surgically, especially with recurrent TIAS in the absence of any other cause. Device was sent to pathology and not as much scar tissue was noted on the side that would have been nearest to the left side of the heart. Since removal, TIAS have stopped, blurred vision of left eye diminished.
NMT MEDICAL, INC./PFO CARDIOSEAL Model: 33MMThe patient had a Cardioseal device placed approximately one month prior for Patent Foramen Ovale (PFO). The patient had a history of prior stroke and presented with current visual disturbances and a near-syncopal episode. Transesophageal echocardiogram (TEE) revealed adequate closure of the Atrial Septal Defect (ASD). However, there were areas of thrombus adjacent to the closure device on the left atrial side. As a result, the closure device was removed and primary repair of the ASD was performed.
AGA MEDICAL CORPORATION/AMPLATZER Lot: M06K16-18Patient arrived on the unit, status post device closure of ASD (atrial septal defect). The patient was responsive on arrival with stable vital signs and was interactive. Within one hour of arrival on the unit, patient had sinus tachycardia after vomiting and returned to baseline. Ten minutes after emesis, patient complained again of persistent nausea, vomiting with red tinge in emesis and complaint of feeling unwell. Sinus tachycardia occurred while vomiting. Fellow was notified - 2 RNs were present at the bedside. Patient became unresponsive, eyes rolled back, frothing at the mouth. Code light was activated. Patient became bradycardic to 30, MD and RN staff responded to the event. Patient was tonic, pulseless, and apneic. CPR was initiated. Cardiac code was called with fast response by cardiac code team. 2 rounds 1ml 1:100,000 Epinephrine were administered resulting in return of heart rate to 70, sinus rhythm with perfusion, chest compression held with bag-mask ventilation. Oral airway was inserted. Transferred to other unit within 6 minutes of event onset.
AGA MEDICAL CORPORATION/AMPLATZER A 24MM Amplatzer device was placed in secundum for an (ASD) atrial septal defect. Position confirmed by TEE(transesophageal echocardiogram) and fluoroscopy. Immediately upon release of the device, it embolized into the left atrium (LA), and subsequently into the left ventricle (LV). Multiple attempts to retrieve the device were unsuccessful.Patient was
taken to the OR for operative removal of the device and closure of the ASD.
AGA MEDICAL CORPORATION/AMPLATZER Model: 10 FR 45 DEGREE X 80 CM Lot: M06J19-58
Patient undergoing atrial-septal defect repair. A 6 french standard sheath was placed in the right femoral vein. Then the intracardiac echocardiography (ice) catheter was advanced to the right atrium and under guidance from ice, a multipurpose catheter was utilized to go across the asd over a rozen wire. After this the balloon sizing Amplatzer balloon was utilized. This showed the ASD to be roughly 27 mm. after this, the Amplatzer device was advanced and during deployment there was embolization into the pulmonary artery. After this, multiple attempts were made at device extraction using multiple catheters. The jr-4 guide, the multipurpose guide, a left internal mammary artery guide, were the catheters that were utilized. Using multiple steering devices such as the 6 French and snare 7 French, an RV biopsy forceps and vascular retrieval forceps and other devices from endoscopy the device was pulled back into the common illiac. After this, the 9 French sheath was exchanged for a 14 French sheath and further attempts made, however, the device could not be retrieved and
vascular surgery was contacted for surgical removal of the device from the right common iliac vein.
AGA MEDICAL CORPORATION/AMPLATZER Model: 9-ASD-010 Lot: M07D24-44 A 10-MM Amplatzer septal occluder was selected; however, the device was malformed on delivery and removed without consequences. Attempts at reconfiguring the device were unsuccessful, and it was felt to be related to a manufacturer's abnormality.
AGA MEDICAL CORPORATION/AMPLATZER Model: 9-ASD-016 Lot: MO7J26-19Difficulty loading a16 mm device into an 8 fr. delivery sheath. We changed to a 9 fr. delivery system. The device loaded appropriately, appeared normal going through the sheath but had a cobra like appearance when released into the atrium. The device retracted into the sheath and was removed from the patient without harm. The device was given to the manufacturer.
AGA MEDICAL CORPORATION/AMPLATZER Lot: MO7K23-08ASD closure device appeared to be seated well on the rims with ice and was deployed. The device migrated to the left ventricle, then to the aortic arch. The device was retrieved to the level of the iliacs in the aorta. Patient was then taken to the operating room for extraction of the device by vascular surgery. Patient tolerated the procedure without complications. Patient will need to be rescheduled for closure of ASD.
W.L. GORE AND ASSOCIATES, INC./ HELEX Catalog: HX1525The patient underwent an implantation of a gore helex septal occluder device to close a patent foramen ovale. Several days later, the patient developed an exertional dyspnea after lifting her child from a stroller. Evaluation in the cardiac services clinic and in radiology revealed embolization of the device from the atrial septum to the abdominal aorta. The patient had the device successfully removed from the aorta seven days after the implant.


Summary of MedSun Reports Describing Adverse Events Involving Burns or Fires during Surgery in the Head and Neck Area

The purpose of providing this summary, and the following reports, is to inform you about problems reported to FDA by the MedSun clinical community. These, as well as non-MedSun reported problems involving this device may also be investigated by searching FDA’s on-line MAUDE database http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm.


Over the past 2 years, MedSun has received 8 adverse event reports involving fires or burns associated with the use of ESU, laser or cautery devices during surgery in the head or neck area. The proximity of the procedures to an oxygen enriched atmosphere is often a contributing factor to these occurrences. The reports were submitted by 8 different hospitals between December, 2006 and January, 2008. The surgical procedures represented in these reports were:

• 4 tonsillectomy and/or adenoidectomy procedures
• 2 tracheotomy procedures
• 1 laser procedure in the patient’s lung
• 1 surgery to remove lipoma on the neck

No reports involved a patient death. The patient injuries listed below were reported in 4 of these 8 reports. In the other reports, prompt intervention by the clinicians appears to have prevented a patient injury.
• 1st and 2nd degree burn – procedure aborted
• Minor burn in mouth - tonsillectomy
• Patient, bronchoscope, laser fiber and trach tube showed evidence of a burn.
• Patient’s chest hair was singed – no apparent burn
• 2nd degree burn to trachea and bronchi

Of the reports that listed patient age, 4 had a patient age listed as less than 21 years and 3 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 4 reports involved female patients and a total of 3 reports involved male patients.

These MedSun reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.


BURNS OR FIRE DURING ESU / LASER PROCEDURES OF THE HEAD OR NECK
Device Device Identifiers Event Description
Electrosurgical Pencil (Covidien Valleylab) E2450HN5B (part of kit) While undergoing excision of lipoma of neck, the surgeon used an electrosurgical pencil to cauterize a bleeder. The pencil was noted to be arcing. Immediately thereafter, fire was observed under the drape.
Electrosurgical Pencil (Covidien Valleylab), Electrode, ESU, bipolar forceps (Covidien Valleylab), Electrode, ESU, bipolar forceps (Aesculap), Generator, ESU, Argon beam (Conmed Electrosurgery)various This incident was reported to me from nurse manager, circulator, and scrub person. Patient status post tonsillectomy bleed. The surgeon was using both a bipolar and a monopolar cautery on the case. The Valleylab bipolar forceps were used as a retractor to expose behind the base of the tongue. It was not attached to the cautery machine. The Aesculap bipolar forceps and the Valleylab suction coagulator E2505-10F were used to resect the uvula and cauterize the tonsillar fossa. The surgeon stated the only explanation he could give for the source of the burn was current flow to the retraction forceps. He stated that the area that was cauterized was always in his direct view, and no arcing or sparking was noted.
Laser System (Laserscope) Model 813 KTP 100W YAG, DP with 630 dye ModuleDoctor was performing laser surgery in patient lungs in an oxygen enriched environment, which resulted in burns to the patient as well as the bronchoscope, laser fiber, and tracheal tube.
Electrosurgical Pencil (ConMed Electrosurgery) Conmed Hand Control with UltraClean, Catalog 131309 When using cautery in the mouth during a tonsillectomy and adenoidectomy (T&A) procedure, the doctor reported a flash (fire). The bovie tip and the tonsil sponge were immediately removed from the mouth. The sponge showed some evidence of a burn. Evaluation revealed the mouth and airway did not seemingly suffer any burns as a result of this incident.
Ablation wand, ENT (Arthrocare Corporation) ArthroCare ENT CoblatorDuring tonsil/adenoid surgery, coblator stopped working properly; smoke coming from tip of probe. MD unable to clear tissue. Used second device, and it worked properly.
Generator, ESU (Covidien Valleylab) Model Unknown During a tracheotomy the patient's O2 saturation began to drop. This required an increase in oxygen to 100%. This caused spillage of oxygen out of the mouth into the area of the wound. There was a short flash of fire on the chest secondary to electrocautery. The fire was put out with sterile water. The patient's chest hair was singed. No apparent burn.
Electrode, ESU, suction coagulator (Covidien Valleylab) Model: E2505-10FRWhile the surgeon was cauterizing the adenoids, the oral cavity caught fire. Saline solution was poured into the mouth. There was no injury to the patient.
Generator, ESU (Covidien Valleylab) Brand: Force FX A spark was noted at the time of the tracheotomy at the insertion site, while a bleeder was being cauterized. Oxygenation was stopped immediately, the endotracheal tube removed, and a tracheal tube inserted. The trachea was flushed with normal saline, cleaned and suctioned. A fiber-optic evaluation of the trachea and bronchi was done, which revealed a possible second degree burn.

Additional Information:

MAUDE - Manufacturer and User Facility Device Experience
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

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Updated May 1, 2008

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