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U.S. Department of Health and Human Services

MedSun: Newsletter #37, June 2009

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Newsletter #37, June 2009

Articles

All FDA Websites are being redesigned, MedSun too!

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All FDA.gov websites including our MedSun newsletter-based website will be changing! This redesign is part of an ongoing initiative which aims to improve the "look and feel" of all FDA websites. These enhancements will help our audiences find relevant information the FDA provides to consumers, to health professionals, as well as to industry representatives.

The MedSun website still provides you with:

*Monthly homepage updates to include:

Articles geared for general and for Subnetwork audiences that address device issues which have an impact on patient safety.
MedSun Subnetworks are designed to collect and share information about adverse events from specific clinical areas with high-risk products. For more information see the ‘About MedSun’ section.

Highlighted Reports which represent a cross section of device-related events submitted by MedSun reporters.

Medical Device Problem Summaries to include medical device problems summarized from de-identified reports received by MedSun hospitals.

Device Problem Reports received in the past 30 days from access date. Reports are organized by general device category and further organized by device type.

*Access to Educational Materials which may be used to educate staff about Adverse Event reporting and how to recognize reportable events.

*MedSun newsletter content
This page provides you the option to access the current newsletter issue, see a complete listing of newsletter content within the following Newsletter sections: "Medical Device Problem Summaries” and "MedSun in Action," or "Search Newsletter Archives" to seek past MedSun Newsletter content for topics of interest.

*Access to de-identified MedSun Reports
These device reports capture a wide range of experiences ranging from deaths and serious injuries to malfunctions, close calls, and potential for harm events associated with the use of medical devices. No patient or user facility identifiers are included.


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2009 H1N1 Influenza

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FDA H1N1 Website

FDA is working to address human infection with the 2009 H1N1 flu virus as part of a team led by the Department of Health and Human Services. FDA is responding to this threat by working with other government agencies and manufacturers on a series of issues related to antiviral medications. FDA and the Federal Trade Commission are also alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. To provide the latest information, FDA will update this Web page regularly.

Additional Information:

2009 H1N1 Swine Flu Virus
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm

FDA Press Release. FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products. May 1, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149576.htm

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Recall (field corrective action) - Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump

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FDA Website

Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the "up" and/or "down" buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the "up" and/or "down" buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.

Additional Information:

FDA Press Release. Disetronic Medical Systems Inc. (a member of the Roche Group) announces a recall (field corrective action) of the ACCU-CHEK® Spirit insulin pump due to “up” and/or “down” button failures. April 30, 2009.
http://www.fda.gov/Safety/Recalls/ucm144111.htm

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Recall of Biosite brand Triage Cardiac Panel

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FDA Website

Biosite and FDA notified healthcare professionals of the Class 1 recall of the Biosite brand Triage Cardiac Panel, a test is used by health professionals as an aid in the diagnosis of a heart attack (myocardial infarction).The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have. Lot #W44467B, shipped as 25 individually pouched devices per kit box, was distributed from January 24, 2009 through February 17, 2009. On April 27, 2009, the company sent an urgent recall notice to customers who were instructed to immediately discontinue all use of, and to discard, all affected products.

Additional Information:

FDA Recall Notice. Class 1 Recall: Biosite Incorporated, Triage Cardiac Panel. April 27, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm149803.htm

Biosite brand Triage Cardiac Panel FDA MedWatch Alert. May 8, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150579.htm

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Enhancements to the CDRH Event Problem Codes

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The CDRH Event Problem Codes refer to any of the codes (Device Problem, Device Component *new* or Patient Problem) that are used to describe a reported event. User facilities and importers provide patient and device problem codes in Block F10, Event problem codes.

Recent enhancements have been made to the Event Problem Codes to improve code selection, as well as to promote adverse event report analysis. CDRH will begin accepting the updated codes on July 1, 2009. All inactivated and retired codes will no longer be accepted as valid on April 2, 2010.

You may visit http://www.fda.gov/cdrh/problemcode/ to see more about the code enhancements, as well as tools that have been created to assist you in viewing and selecting the appropriate Event Problem Codes.

Additional Information:

CDRH Event Problem Codes. Online Available:
http://www.fda.gov/cdrh/problemcode/.

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The Joint Commission releases an educational monograph: Measuring Hand Hygiene Adherence: Overcoming the Challenges.

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The Joint Commission

Preventing infections is critical to patient safety. Effective hand hygiene practices have long been recognized as the most important way to reduce the transmission of potentially deadly microorganisms in health care settings. But it is critical to follow-up the implementation of hand hygiene policies and protocols with evaluative monitoring of their effectiveness.

To help health care organizations target their efforts in measuring hygiene performance, The Joint Commission (JC) has released “Measuring Hand Hygiene Adherence: Overcoming the Challenges.” In addition to the JC, the collaborating organizations participating in developing the monograph included the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC), the Centers for Disease Control and Prevention (CDC), the Society for Healthcare Epidemiology of America (SHEA), the World Health Organization (WHO) World Alliance for Patient Safety, the Institute for Healthcare Improvement (IHI) and the National Foundation for Infectious Diseases (NFID).

In 2004, The World Health Organization (WHO) World Alliance for Patient Safety initiated a global response to the problem of health care–associated infection, with a major emphasis on the promotion of hand hygiene in health care. Many of the measurement and improvement tools developed for initiatives within and across countries are publicly available (links thereto are provided in the monograph); are widely field tested; and are well worth considering for use in your organization.

The report provides a critical appraisal, including the advantages and disadvantages, of the three main methods for measuring hand hygiene performance, which are:

• Directly observing
• Measuring product use
• Conducting surveys

Simple charts and graphs can make data—such as data on when health care workers clean their hands and how they clean their hands—easy to interpret and use. A quality dashboard can provide an organization’s leadership with a quick, at-a-glance summary of structure, process, and outcome. It is useful to stratify data by subgroups, such as specific hand hygiene opportunities or types of health care workers. Statistical process control charts are useful for revealing trends in data over time and can help you determine whether changes in rates are a result of specific interventions or due to normal variation.

Additional Information:

Measuring Hand Hygiene Adherence: Overcoming the Challenges. The Joint Commission. April 14, 2009.
http://www.jointcommission.org/PatientSafety/InfectionControl/hh_monograph.htm

Measuring Hand Hygiene Adherence: Overcoming the Challenges. Hand Hygiene Monograph. Available:

http://www.jointcommission.org/NR/rdonlyres/68B9CB2F-789F-49DB-9E3F-2FB387666BCC/0/hh_monograph.pdf

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Information about Unique Device Identification (UDI)

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In 2007, legislation was passed that says the FDA must develop a standardized system to uniquely identify medical devices (Unique Device Identification - UDI). Manufacturers will have to place the UDI in human readable and/or AutoID formats on a device, its label (packaging) or both. The FDA will also have to create and maintain the UDI Database.

A recent FDA workshop focused on the standards that are being used to initiate UDI. The development and use of the UDI Database (UDID), adoption and implementation of UDI by other stakeholders and issues with the placement of UDI were also discussed. For more information about this workshop, see the April 2009 article titled, “Raising UDI’s Profile on the Flagpole.”

There are many benefits to adopting UDI. The article titled, “Change the Forecast from Perfect Storm to Perfect Order” discusses how bar-coded products and point-of-care scanning can assist hospitals with important patient safety initiatives by tracking products, recording serial numbers and managing expiration dates. Hospitals and some suppliers are now rallying behind a single set of GS1 standards that can be used to drive down hospital costs, create efficiencies, and ultimately improve patient safety.

Recalled products used on a patient can cause adverse outcomes. Sometimes, hospitals continue to use recalled products unknowingly because it is hard to keep track of every medical device and product. New legislation will require manufacturers to label their products with UDIs. The article titled, “UDI Goes Beyond UPN in Identifying Recalled Products, Preventing Surgical Dangers,” explains how UDI can help track recalled products and provide benefit to patients and health care facilities, alike. Once UDIs are put into place, every sector of the U.S. health system will be able to identify where the product was used and which product continues to be used.

See Additional Information below for access to these resources.

Additional Information:

Raising UDI’s Profile on the Flagpole. Perrin, Richard. Healthcare Purchasing News. April 2009.
http://www.hpnonline.com/inside/2009-04/0904-PnP-UDI.html

Change the Forecast from Perfect Storm to Perfect Order. Gundersen, Steve. Healthcare Purchasing News. January 2009.
http://www.hpnonline.com/inside/2009-01/0901-SP-BD.html

UDI Goes Beyond UPN in Identifying Recalled Products, Preventing Surgical Dangers. Cooper, Mitch. Healthcare Purchasing News. March 2009.
http://www.hpnonline.com/inside/2009-03/0903-StandProc.html

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Nurses Hesitate to Report Errors

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American Mobile Nurse Healthcare (AMN)

Nurses know the value of reporting errors but feel conflicted about disclosing a mistake, according to a recent study in the Journal of Patient Safety. Nurses in the focus groups indicated time pressures as a factor in not reporting, along with whether or not the patient was harmed. They also said they received little feedback when they did formally disclose a mistake, which reinforced perception that reporting is not meaningful.

Additional Information:

Nurses Hesitate to Report Errors. American Mobile Nurse Healthcare (AMN) – Nursing News. 2009.
http://www.nursezone.com/nursing-news-events/more-news.aspx?ID=18857

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Hospital Survey on Patient Safety Culture: 2009 Comparative Database Report

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AHRQ (Agency for Healthcare Research and Quality)

On average, over half (52 percent) of hospital staff surveyed did not report any medical errors in their hospital over a 12-month period , according to a report based on data from nearly 200,000 hospital staff from 622 hospitals nationwide. The Hospital Survey on Patient Safety Culture: 2009 Comparative Database Report is an update that summarizes the latest results from hospitals that have administered the AHRQ Hospital Survey on Patient Safety Culture. Teamwork within hospital units and supervisor and manager support for patient safety are areas of strength for most hospitals, but non-punitive response to error and handoffs continue to be main areas for improvement in patient safety culture. Trend analyses found that hospitals with improvements over time in non-punitive response to error had slight increases in event reporting.

Additional Information:

Hospital Survey on Patient Safety Culture: 2009 Comparative Database Report. AHRQ (Agency for Healthcare Research and Quality). April 2009.
http://www.ahrq.gov/qual/hospsurvey09/

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HomeNet

Information on Home-Use Tests

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FDA OIVD (Office of In-Vitro Diagnostics) Website

Home-use tests are intended to help you with your health care, but they should not replace periodic visits to your doctor. Many times, you should talk to your doctor even if you get normal test results. Most tests are best evaluated together with your medical history, a physical exam, and other testing. This section provides information about home-use tests to screen for certain diseases or conditions.

Additional Information:

Home-Use Tests. FDA OIVD Website.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/default.htm

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KidNet

Recall of Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003

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FDA Website

Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003, used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitors may fail to sound an alarm during periods of temporary interruption of breathing or low heart rates. The affected products were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.

Additional Information:

FDA Recall Notice. Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003. May 18, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm152725.htm

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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 March 1 through March 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.


CARDIOVASCULAR


Device: Stent, Superficial Femoral Artery, Self-expanding
Manufacturer: EV3 Inc.
Brand: Protege Everflex
Lot #: 4960631
Cat #: VBC061502

Problem:

The stent did not deploy fully open. It shortened and became very distorted. The stent shortened to half of the specified length. The patient required additional ballooning techniques with multiple balloons and placement of two viabahn covered stents. The end result was an open SFA.

FDA comment: Not approved for peripheral use in the United States.


Device: Catheter, Balloon, Dilatation
Manufacturer: Boston Scientific Corp.
Brand: Ultra-thin Diamond Balloon Dilatation Catheter
Model #: M001164830
Lot #: 9228437
Cat #: 16-483

Problem:

Poorly functioning arteriovenous fistula. Balloon rupture during PTA of in-stent re-stenosis. All pieces retrieved. Per Director of the unit, rupture may have been prevented if inflator was utilized.


Device: Defibrillator, External
Manufacturer: Medtronic Emergency Response Systems
Brand: Lifepak 20
Model #: LP-20
Problem:

During surgical procedure, a synchronized cardioversion attempt was made with the device in manual mode. Upon pressing the sync button and observing proper operation, the defibrillator was charged to 360J. After a shorter than expected time, the unit appeared to be ready for discharge. Upon discharge, the unit gave either a "connect electrodes" or a "remove test plug" message. We are not sure which. The unit gave a service light and continued to give the message. Another defibrillator had to be obtained to provide therapy needed by the patient. Pads checked and compatible with defibrillator.

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Manufacturer response for Defibrillator, Lifepak 20
======================

With Risk Mgmt. approval, call was placed for field service support since the unit is under warranty. The unit gave a 9021 error code at the time of the failure. Their service documentation indicates that newest software should be installed as the corrective action for this. Service rep installed latest software.

Installed Material:
Qty = 1 3203332-019 KIT-UPGRADE,SW,MODULE 070,LP20,ENGLISH

Upon further consideration, the rep took the unit with him to deliver to Regulatory Affairs with the company. He updated software on all other units in our OR areas. I am currently trying to make contact with the representative in Regulatory Affairs to try to get this software installed on the rest of our units. We have 79 of them within our facilities.


Device: Catheter, Ablation
Manufacturer: Biosense Webster
Brand: Navistar Thermocool
Lot #: 13451381
Cat #: N175TCDH
Other #: Ref #34H37M

Problem:

Patient was to receive an RF ablation for atrial fibrillation. The RSPV was accessed without difficulty or resistance. However, the ablation catheter could not be withdrawn beyond the vein. Despite manipulation of the catheter with and without the aid of the trans-septal sheath, the tip of the catheter was affixed to the pulmonary vein. Using Intracardiac Echo and fluoroscopy, the position of the catheter was verified to be in the PV. There was no evidence of pericardial effusion at that time. Despite at least moderate traction, the tip could not be freed. Patient ultimately had to be transferred to surgery so that a sternotomy could be performed. The ablation catheter was then able to be removed and a full left atrial Maze procedure was done. Post-op course uneventful and patient was discharged home on post-op day 3.


GENERAL HOSPITAL

Device: Hospital Bed
Manufacturer: Stryker Medical
Brand: Secure Ii Med/surg Bed
Model #: Secure 2, 3002EX

Problem:

Brakes were activated, but bed rolled under moderate pressure.

FDA comment: FDA has received other reports on this issue


Device: Infusion Pump
Manufacturer: Baxter Healthcare Corporation
Brand: Flo-gard
Model #: 6301

Problem:

A 5 ml/hr insulin drip was ordered. The medication and the pump settings were verified by two other RNs. The pump was set to infuse at 5 ml/hr, and the total volume to be infused was 20 ml. After 1 hour the pump began alerting "air". The pump had infused the total dose in less than one hour. The patient did not have any adverse effects other than an increased stay in ER.

======================
Manufacturer response for infusion pump
======================
Sent in the pump and spoke to Baxter via phone. No response until after they receive pump and test it.


Device: Sponge Applicator, 26ml Applicator
Manufacturer: Cardinal Health Skin Prep
Brand: Chloraprep with Tint
Model #: 260815
Problem:

The left neck was prepped with tinted chloraprep. Area draped. After working on other areas around the face, the left neck was undraped (approximately 35 minutes after prep). A flash fire occurred when the ESU was ignited. Superficial partial thickness burns occurred to the posterior neck, ears and upper back.

Additional information obtained from the site:
? Product # 260815, 26ml applicator
? The patient experienced first and second degree burns.
? Valleylab Force FX-C, F2C 21244A


Device: Stretcher, Patient, Hospital
Manufacturer: Styker Medical
Brand: Stryker Stretcher
Model #: 0735
Problem:

Transferring patient from stretcher to procedure table, found brakes not working. Healthcare professional had to put their body against the stretcher to keep it from moving away from procedure table during patient transfer.

Recall available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=65428

Device: Iv Tubing
Manufacturer: Baxter Healthcare Corporation
Brand: Continu-flo Solution Set
Model #: 2C6537s
Lot #: S08125091R (probable)

Problem:

The sister of a patient ran out of the room to find a nurse to call for help. She yelled, "patient is bleeding.” Two RN's entered the room to find a significant amount of blood on the floor. Tubing was connected to a central line (broviac), and the connection was intact. However, there was fluid and blood dripping partway out of the primary IV tubing. A hole in the tubing was observed. The patient was stable. The patient’s hemoglobin level was 12 on admission and 10.9 the following day. The break to the sterile IV system puts this oncology patient at greater risk for a blood stream infection. There was a potential for greater blood loss had there not been someone at the bedside.

Device: Infusion Pump
Manufacturer: Hospira Global Medical Affairs
Brand: Symbiq
Model #: 1602604
Cat #: 1602604

Problem:

The IV pump was attached to the IV pole. The nurse stepped out of the room and heard a noise. The nurse returned to find the IV pump on the floor with the pole clamp still attached to the IV pole.

======================
Manufacturer response for Infusion Pump, Symbiq
======================
The manufacturer requested the pump be sent in for evaluation.


ANESTHESIOLOGY

Device 1: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 2: Anesthesia Machine
Manufacturer: GE HEALTHCARE
Brand: Aisys Carestation
Model #: S5AISYS

Device 3: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 4: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 5: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 6: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Device 7: Anesthesia Machine
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5AISYS

Problem:

During a scheduled Preventive Maintenance inspection, it was noticed that there was rust on the Rod of the Bag/Vent Switch assembly. The assembly was replaced with a new part. The suspected part was sequestered.

======================
Manufacturer response for ANESTHESIA MACHINE, ANESTHESIA MACHINE
======================
GE acknowledges that there is a problem, and are in the process of sending us an official letter, after their analysis and investigation is complete. The presence of Chloride in their manufacturing process, either during machining or cutting is contaminating the parts causing them to rust. They initially were using stainless steel grade 303 and switched to SS 313.


Device: Carbon Dioxide Absorbent
Manufacturer: Armstrong Medical
Brand: Amsorb Plus
Lot #: 220908F21
Problem:

This report involves the Amsorb CO2 filter on two of our anesthesia machines. The part that monitors the CO2 levels indicated that the inspired CO2 was increasing during a surgery. Biomed discovered after investigating that the problem was the Ambsorb container. (This product turns from white to violet when used, but in this case the product was still white.) Biomed looked at the canisters on all the machines and found one other failure where the device was not working as intended. The Biomed Tech noted that the two malfunctioning canisters had the same lot number. All products with that lot number at our facility were pulled off the shelf. The company has been contacted and they will be receiving the malfunctioning canisters for investigation.

======================
Manufacturer response for Carbon Dioxide absorbent, Amsorb Plus
======================
They will be testing the device

Device 1: Ventilator
Manufacturer: Newport Medical Instruments
Brand: E-500
Model #: E-500

Device 2: Nurse Call System
Manufacturer: Simplex Grinnell
Brand: Ez-care

Problem:

When the ventilator triggers an alarm it also triggers the nurse call system (Simplex Grinnell EZ-Care), the ventilator resets itself and so should the nurse call, but in some instances the vent nurse call port gets stuck or locks and keeps sending a signal to the nurse call system even if the vent is not alarming. We have to bag patient and reset power to vent to clear. Sometimes it does not work so we have to remove vent and install another vent.

======================
Manufacturer response for Ventilator
======================
We have complained several times over the past year, we have changed cables as they requested. They have been unable to find out the cause.


RADIOLOGY

Device: Computed Radiography Plate Reader
Manufacturer: Fujifilm Medical System, USA, Inc.
Brand: Fuji Fcr Xg5000
Model #: FCR XG5000
Cat #: CR IR 362

Problem:

While tech was developing an X-ray image in the Fuji CR reader, he noticed prior to sending to PACS, that images were incorrect. They "jumped into another patient's jacket". A service call was placed and Fuji service engineer came in. Logs were sent to Japan for review.

A similar event occurred approximately a year ago. The hospital believes that this problem may be triggered when a jam of a CR cassette occurs, and the CR reader is re-booted to clear the jam. Under these circumstances it appears that the CR image may be stored in the proper (new) patient's folder, as well as in the previous patient's folder (bearing the accession number of the new patient).

Fuji identified the cause of the issue and has installed a software upgrade Version 2.5 in the CR reader, which they have stated will prevent a repeat occurrence of this problem. The hospital has 13 of these CR readers and is in the process of having the upgrade installed in the other readers.


GENERAL & PLASTIC SURGERY

Device: Kit, Iv Site Prep
Manufacturer: Churchill Medical Systems, Inc.
Brand: Churchill Medical System
Model #: AMS-796CP
Lot #: 810124

Problem:

During an IV start for surgery the ChloraPrep Frepp sponge was activated and glass fragments were in the sponge leading to a superficial cut on the patient's arm.

======================
Manufacturer response for IV start kit, Churchill Medical System
======================
will evaulate the product


Device: Breast Biopsy Marker
Manufacturer: SenoRx, Inc.
Brand: Gel Mark Ultra
Lot #: 08H0725
Cat #: MK2011

Problem:

A breast biopsy marker was utilized during an uneventful stereotactic breast biopsy. A followup X-ray of the breast displayed both the marker as well as unknown metallic objects in proximity to the marker that were not intended to be left in the biopsy location.

The radiologist believes that the biopsy marker insertion tool left the unidentified metallic pieces behind. This belief is supported by the fact that an unopened biopsy insertion tool from the same lot was X-rayed and found to have a similar metallic object floating separate from the clip.

See images of fragment clip in breast tissue and the fragment clip in unopened package, respectively:

Clip with fragment in unopened package

Clip in breast tissue

Device: Wound Therapy System
Manufacturer: Kinetic Concepts, Inc.
Brand: Wound VAC
Model #: 60090

Problem:

Pump alarming "canister not engaged." However, the canister was never moved, nor was it touched in anyway since the patient arrived back from OR. Several attempts were made to take out and re-place the canister without success in fixing the alarm, also an electrical cord was found and cleaned and engaged to wound VAC without success. Several attempts at turning wound VAC entirely off then on again also did not fix the alarm. Another Wound VAC was secured and this wound VAC was replaced.

======================
Manufacturer response for Wound VAC, Wound VAC
======================
Wound VACs are rental devices from KCI. KCI maintains wound VACs.


Device: Kit, Laryngotracheal, Anesthesia
Manufacturer: Hospira
Brand: Lta 360 Kit
Model #: NDC# 0409-4698-01
Lot #: 63-295-R1
Cat #: 4698-01
Problem:

During vocal cord injection Laryngotracheal Anesthesia (LTA) glass vial broke [kit contains lidocaine].

Looked to be intact upon removal from package and was primed without problem.

Device 1: ESU, Generator
Manufacturer: Gyrus ACMI
Brand: Gyrus Generator
Model #: G400
Other #: ID # 56T-1993

Device 2: Electrode, ESU, Spatula
Manufacturer: Gyrus ACMI
Brand: Pks Plasma Spatula with Cord
Model #: 952005PK
Lot #: 71069KA or 67281JAJ
Cat #: 952005PK

Problem:

The patient had a laparoscopic hysterectomy. She returned 5 days later with complaint of pain, lleus and ureter obstruction. The patient returned to the OR and they found thermal injury to the bladder and left ureter. They also found thermal injury to the anterior surface of the rectum and the cul-de-sac. These were repaired and the patient had a stent placed and a suprapubic cystostomy tube. The physician felt the thermal spread was caused by the plasma spatula. The device was not saved because we were not aware of the problem till the patient came back in. I have included the 2 lot numbers of the spatulas that we have in the OR.

======================
Manufacturer response for Spatula, PKS Plasma Spatula with Cord
======================
Have not heard from them yet.

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Manufacturer response for Generator, Gyrus Generator
======================
Have not heard from them yet.


ORTHOPEDIC

Device: Implant, Total Artificial Hip, Femoral Head
Manufacturer: Stryker Orthopaedics
Brand: Lfit V40
Lot #: 28759003
Other #: REF # 6260-9-132

Problem:

Patient was in surgery for a hip replacement. The implant was mislabled as a 32mm but was actually a 26mm. The mislabeling was noticed prior to implantation. No harm to patient.

======================
Manufacturer response for Femoral Head, LFIT V40 Femoral Head
======================
The mfg's rep took the mislabled product and substituted with correct size.


GASTROENTEROLOGY & UROLOGY

Device 1: Capsule, Esophageal, Ph
Manufacturer: Medtronic Gastroenterology/Urology
Brand: Bravo Ph Capsule
Lot #: Q255009

Device 2: Catheter, Esophageal Ph
Manufacturer: Medtronic Gastroenterology/Urology
Brand: Bravo
Model #: 9012B1011
Lot #: Q255194
Other #: ID 7428

Problem:

The endoscope was placed at the top of the esophagus to view placement following the Bravo Ph capsule deployment at 31 cm. The suction used for the procedure was appropriate. The device did not completely attach to the inside of the esophagus and slipped down into the stomach. The endoscope showed a small amount of heme and a small lesion on the tissue where the clip attachment was attempted. The patient was transported to the post procedural area without injury.

Device: Introducer Kit
Manufacturer: Kimberly-Clark Corporation
Brand: Mic-key J/tj-16 Introducer Kit
Other #: 98437

Problem:

The introducer kit comes with a set of dilators (progressing from small to large) that are situated on one introducer that is approximately 12 inches long. Each dilator slides down the introducer through an incision made by the provider. There are four such dilators that are slid down in sequence to enlarge the incision. In this event, the first (smallest) dilator came off the end of the introducer into the patient's stomach during J-tube placement. The J-tube was placed inadvertently, and unknowingly, over this dilator. When the provider cut the tack/sutures to allow the stomach to return to its normal position, the J-tube was able to "pop" out of the hole made in the stomach. As a result, the J-tube communicated with the peri-gastric abdomen rather than the stomach. Tube feeds were started which emptied into the patient's abdomen. The patient was subsequently taken to the OR for washout where the unintentionally retained object was discovered. The dilator was able to slip off the end of the introducer (not designed to do so), and into the stomach unnoticed. Further, the dilator is not radiopaque so it cannot be detected on radiograph post procedure, or fluoroscopically. This was an isolated event. The reporter states that this is a new product, as within the last 12 months. It is believed that the device failed.

Dilator within Introducer Kit

Device: Feeding Enteral Tube W/stylet
Manufacturer: VIASYS Healthcare MedSystems
Brand: Feeding Enteral Tube W/stylet
Lot #: 34947
Cat #: 20-9225

Problem:

The infant was witnessed dislodging her nasogastric tube. A new tube was obtained and placed without difficulty in the opposite nares. The tube feeding was hung. This RN had checked on the patient several times over the following forty minutes, and the feed appeared to be infusing without incident. The feeding was noted to be done, but the patient was noted to be fussy, as if still hungry. When disconnecting the feed, the patient's bed was noted to be saturated with feed. The nasogastric tube was noted to be in place and all the connections were intact, but when this RN took a flush syringe and flushed the tube there was leakage noted at the connection point between the nasogastric and the clear y-connector. This is where the feed port and med port are attached.


HEMATOLOGY

Device 1: Analyzer, Blood Coagulation
Manufacturer: International Technidyne Corporation
Brand: Hemochron Jr. Signature +

Device 2: Analyzer, Blood Coagulation
Manufacturer: International Technidyne Corporation
Brand: Hmeochron Jr. Signature +

Problem:

Cath Lab manager reports concerns with either Hemochron Jr./Signature + machines or possibly the Cuvettes which were being utilized. At time in question, Cuvette ACT+ were being used. We are now using ACT-LR. Below is a summary of what happened, but we cannot definitively say there was a "malfunction". It was reported that while using the Cuvette ACT+, the times were lower with the amount of heparin given in some procedures. Our cath lab compared results using one blood sample between two Hemachron machines and a different mfr's machine. In one particular instance, the sample results were: The different mfr's machine read 219, Hemochron (both machines) read 171. These results were run simultaneously, side by side. The request had come from the physician when results from the same three machines, 50 minutes earlier showed the result from the different mfr's machine as 409. One of the Hemochron machines showed a result as 171 and the other Hemochron machine was not recorded. To summarize, when the cath lab used the ACT+ the times seemed to be low. We did not change our QA process and the numbers showed we were within ranges for the tests. We have since gone back to the ACT-LR and our physicians now have the confidence to believe the results.


Device: Analyzer, Hematology
Manufacturer: SYSMEX AMERICA, INC.
Model #: 2100

Problem:

The machine had a temperature error. The temperature was reset by turning the machine off and on. Ultimately, the entire red cell block was replaced by SYSMEX. Erroneous results were reported on several patients. Only one is listed in this report since it involved the same piece of equipment. No patient harm has come from this incident.


Device: Analyzer, Chemistry
Manufacturer: Siemens Healthcare Diagnostics
Brand: Advia Centaur Xp

Problem:

It was determined by the Siemen's engineer that the problem with the Centaur was a defective water valve. A piece of tubing came loose, and was flooding the bottom of the analyzer. Despite the condition, the machine flagged red and yellow, but continued to function albeit incorrectly. An engineer from Siemens was available and made the necessary repairs to the unit. It was back on line later that day.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Cardiac RF Ablation Catheters

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A cardiac ablation catheter is a long, thin tube that is threaded into or onto the heart to destroy (ablate) an area of heart tissue that is causing abnormal heart rhythms. Cardiac ablation catheters are used to treat abnormally rapid heartbeats that cannot be controlled with medication, or in patients that cannot tolerate these medications. They are used most often to treat abnormal rhythms that begin in the upper heart chambers (atria). Some examples are Supraventricular tachycardia (SVT), Atrial Tachycardia, and Atrial Flutter. Less often, ablation can be used to treat heart rhythm disorders of the lower heart chambers (ventricles). [1]
Over the past 2 years, MedSun has received 27 adverse event reports associated with the Cardiac RF Ablation Catheter. The reports represent 3 manufacturers: 19 reports for Biosense Webster, 7 reports for Boston Scientific, and 1 report for St. Jude Medical. The reports were submitted by 7 hospitals between April 21, 2007 and April 21, 2009. The reported device problems were:

• Failure to deflect/straighten/directional control (6)
• Carto display error/failure to recognize catheter (5)
• Electrical interference (noise) on EKG channel (4)
• Inability to remove catheter/broken fragments remain in patient (3)
• Unexpected bend or curve in catheter (2)
• Temperature function/reading failures (2)
• Stopped working (2)
• Connection problems (1)
• Perforation (1)
• Failure to flush (1)

There were no MedSun reports that involved a patient death. The majority of reports did not involve any patient injuries. Patient problems were reported in 4 of these 27 reports.
• Break in the catheter/tip requiring surgical intervention to remove (3)
• Pericardiocentesis (1)

Of the reports that listed patient age, all had a patient age listed as greater than 21 years. A total of 8 reports involved female patients and a total of 16 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. The following recall, describing problems with deflection are noted to be associated with the Biosense Webster Lasso Catheter.

Recall Number: Z-1703-2008 and Z-1704-2008. See FDA weekly enforcement report for more details about the recall.

This recall was initiated on March 25, 2008 by Biosense Webster for the Lasso 2515 Variable Circular Mapping Catheter, US Catalog Number D7L202515RT.

This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and separation of the distal end of the catheter may occur. Also, the firm determined that when the catheter is fully deflected and the variable loop is fully contracted, it is possible that the catheter mechanism can become "locked" in position and cannot return to the un-contracted, un-deflected state. This could lead to damage to the device or limit the ability to withdraw the catheter safely.

Please note a New Device Approval: NaviStar ThermoCool and EZ Steer ThermoCool Nav Irrigated Deflectable Diagnostic/Ablation Catheter for Treatment of Paroxysmal Atrial Fibrillation
Approval Date: February 6, 2009.

[Note: The reports have been edited for clarity]


Cardiac RF Ablation Catheters
Device Device Identifiers Event Description
Biosense Webster/EZ Steer Nav Bi-directional Catalog # BN7TDD4L; Lot # 13206693AThe temperature function on the Stockert generator failed. The case was delayed while switching out to other generator/catheter. There was no harm to the patient. Biomedical assessment: The problem was the catheter temperature function failed during case. Corrective action/recommendations: Confirmed problem. Sent device to Biosense Webster for evaluation/repair.
Biosense Webster/Lasso No Device Identifiers During ablation procedure the tip of the catheter broke off in the left ventricle. The physician was unable to remove and took the patient to surgery for retrieval (emergency sternotomy). The device tips and catheter will be sent to the company for review. .
Biosense Webster/NaviStar DS No Device IdentifiersWhile undergoing a left atrial ablation for supraventricular tachycardia via a trans-septal approach, the patient sustained perforation of the left atrium. Immediate care was given that included pericardiocentesis, intubation and appropriate drugs. The patient is still an inpatient, but doing well. No surgery was required.
Biosense Webster/NaviStar RMT DSCatalog # NR7TCS8YU; Lot # 13280885 Catheter image did not display onto to the Carto system, preventing the procedure from continuing. All connections were checked and a brand new handle was connected to the catheter. This did not resolve the issue. The catheter was replaced with a brand new duplicate catheter. This resolved the issue. No patient harm was involved due to this issue.
Biosense Webster/NaviStar ThermoCool Catalog # N175TCFH; Lot # 13276491The ECG signal displayed inappropriate noise. All connections were checked and the catheter handle replaced with another handle. This did not resolve the issue. Finally the catheter was then exchanged for another brand-new catheter and this resolved the issue.
Biosense Webster/NaviStar ThermoCool Catalog # N175TCFHThe Carto was not recognizing the catheter. Replaced with a new catheter and problem was solved.
Biosense Webster/NaviStar ThermoCool Catalog # N175TCDH; Lot # 13451381The patient was to receive an RF ablation for atrial fibrillation. The right superior pulmonary vein was accessed without difficulty or resistance. However, the ablation catheter could not be withdrawn beyond the os of the vein. Despite manipulation of the catheter with and without the aid of the trans-septal sheath, the tip of the catheter was affixed to the pulmonary vein. Using intra-cardiac echo and fluoroscopy, the position of the catheter was verified to be in the pulmonary vein. There was no evidence of pericardial effusion at that time. Despite at least moderate traction, the tip could not be freed. The patient ultimately had to be transferred to surgery so that a sternotomy could be performed. The ablation catheter was then able to be removed and a full left atrial maze procedure was done. The post-op course was uneventful and the patient was discharged home on post-op day 3.
Biosense Webster/NaviStar ThermoCool Catalog # N175TCFHThere was no connection with the catheter and the power interface (PI) unit. The handle was changed and then the catheter was changed which finally resolved the problem. No harm came to the patient.
Biosense Webster/NaviStar ThermoCool Catalog # N175TCDH; Lot # 14018966The catheter would not properly deflect.
Biosense Webster/NaviStar ThermoCool Catalog # N175TCFH; Lot # 14027989The catheter would not properly deflect.
Biosense Webster/NaviStar ThermoCool Catalog # N175TCFH; Lot # 14041759The catheter would not straighten. No harm came to the patient.
Biosense Webster/NaviStar ThermoCool Catalog # N175TCFH; Lot # 14025914 The catheter would not flush properly. No harm came to the patient.
Biosense Webster/NaviStar ThermoCool Catalog # N175TCFH; Lot # 14034362The catheter would not deflect. No harm came to patient.
Biosense Webster/NaviStar ThermoCool Catalog # NI75TCFH; Lot # 13354189The catheter displayed noise on the electrocardiogram channel. No warning icon was displayed via NaviStar Carto system. The staff exchanged catheter handle and there was no improvement. The staff exchanged connecting wires of Carto system and again no improvement. Last, staff exchanged the catheter for another brand new catheter and this resolved the issue. There was no harm caused to the patient through this entire issue.
Biosense Webster/NaviStar ThermoCool Catalog # NI75TCFH; Lot # 13383420The error message 202M appeared on the Carto system. All connections were checked. Finally, the catheter was exchanged for a duplicate catheter and this resolved the issue.
Biosense Webster/NaviStar ThermoCool Catalog # NI75TCFH; Lot # 13391891The temperature readings for the ablation catheter were too high. The catheter handle was exchanged for a duplicate handle and this did not resolve the issue. Then the catheter was exchanged for a duplicate catheter and this resolved the issue. There was not any patient harm involved due to this incident.
Biosense Webster/NaviStar ThermoCool Catalog # NI75TCFH; Lot # 13375742 An error message appeared on the Carto system stating, "check mapping catheter connection." This prevented the procedure from continuing. A new catheter handle was used and did not fix the problem. The catheter was replaced with a duplicate, brand-new catheter. This fixed the problem. There was not any patient harm involved due to this issue.
Biosense Webster/NaviStar ThermoCool Catalog # NI75TCFH; Lot # 13276491Electrocardiogram signal on the NaviStar ThermoCool irrigated tip ablation catheter displayed inappropriate noise. All connections were checked and the catheter handle was replaced with another handle. This did not resolve the issue, and finally the catheter was then exchanged for a new catheter, which resolved the issue.
Biosense Webster/QwikStar Catalog # QS7TCF4M; Lot # 13266194After correctly connecting the catheter and catheter handle to the Carto system, the intra-cardiac ECG did not display. All connections were checked. The catheter was then exchanged for another brand-new catheter and this corrected the issue.
Boston Scientific/Blazer II Model # M0045031TL; Lot # 11395455No patient was identified. The catheter torque ability became defective during the procedure. Catheter was exchanged for another catheter. There was no harm caused to the patient from this incident.
Boston Scientific/Blazer II Model # M0045031TK20; Lot # 9506623The doctor was using the device when it was noticed that it had an improper curve. The device was removed from use and replaced with a new catheter.
Boston Scientific/Blazer II Model # 5031TL; Lot # 9435914When the catheter was taken from the packaging, it was found to be bent at the distal end. A new catheter was opened to proceed.
Boston Scientific/Blazer II Model # M0045031TL; Lot # 12034733Non-correctable electrical interference noted from catheter. There was a lot of noise on intracardiac channel. No harm came to the patient.
Boston Scientific/Blazer II Model # 5031T; Lot # 10575002The doctor reports that the ablation catheter was used for 19 ablations when the catheter stopped working. The catheter was removed and replaced with a new device. The patient was not harmed.
Boston Scientific/Chilli II Model # M00490310; Lot # 9777695The patient was undergoing an ablation for atrial flutter. The physician placed an 8 FR sheath in the right groin for ablation purposes. The sheath was easily placed and the ablation catheter was inserted without difficulty. However, when the physician tried to remove the sheath, the ablation catheter became "stuck." The physician was unable to turn the sheath. No extra force was applied. Eventually, the catheter was able to be removed. The physician used another catheter to complete the procedure. There was no patient harm in this event. The manufacturer rep came to the risk management department a few days after the event to see the device, and will have the manufacturer send a mailing label to return the device for evaluation. Per the manufacturer rep, they have experienced this kind of problem before, and are recommending that physicians use a larger size sheath. The physicians were notified and have already changed their practice to increase sheath size from an 8 FR to an 8.5 FR. To date, no other problems with the device have been reported by either the physicians or the cath lab staff.
Boston Scientific/Chilli II Model # M00490310; Lot # 9788662The physician inserted the cooled ablation catheter and was getting it into position. Once there, the physician was unable to get the directional control to work and said it appeared that the catheter was in a "fixed mode." The physician was unable to get the directional control to work and had to remove the catheter. Another catheter from the same company was used--same size--and worked as expected. There were no visual defects seen on the device that did not work. There was no patient harm.
St. Jude Medical/Livewire Model # 402149Patient undergoing cardiac cath and electrophysiology studies of the heart (to check conductivity) were done due to the patient's atrial fibrillation. An ablation catheter was utilized. As the catheter was being advanced towards the tricuspid valve, the catheter broke and ensnared in the tricuspid valve. The catheter could not be removed. Patient was taken to the operating room, chest was opened and patient was placed on bypass so that wire could be removed from tricuspid valve.



Additional Information:

Recall Number: Z-1703-2008 and Z-1704-2008. See FDA weekly enforcement report for more details about the recall, online available:
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm161725.htm

New Device Approval: NaviStar ThermoCool and EZ Steer ThermoCool Nav Irrigated Deflectable Diagnostic/Ablation Catheter for Treatment of Paroxysmal Atrial Fibrillation February 6, 2009.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm125525.htm

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Updated June 1, 2009

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