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November 15, 2010 vol. 19:16

FDA Recalls and/or Manufacturer Product Advisories and Field Corrections

Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.

FDA MEDWATCH Posting: November 12 & 15, 2010

Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

ISSUE: FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700. These units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

BACKGROUND: The recalled pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. The recall was initiated September 14-15, 2010 and includes serial numbers from 706497 to 724065, manufactured between October 2006 and March 2008 (17,568 pumps.) Serial numbers are located on the bottom panel.

RECOMMEDATIONS: Sigma has instructed healthcare facilities to verify whether the serial numbers for their infusion pumps fall within the range of pumps being recalled and is requiring the return of the recalled devices. Sigma has instructed users to not use the infusion pumps on patient populations, including neonatal patients, where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death.

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FDA launches initiative to develop innovative external defibrillators: FDA Posting November 15, 2010

Safety concerns on the devices that treat abnormal heart rhythms also to be addressed

The U.S. Food and Drug Administration today announced a program aimed at facilitating the development of safer, more effective external defibrillators used to treat abnormal heart rhythms through improved design and manufacturing practices.

External defibrillators are medical devices designed to diagnose life-threatening abnormal heart rhythms and treat them by delivering electrical energy to the heart to restore its normal rhythm. When used in the first few minutes following a cardiac arrest, they can save lives. External defibrillators are used successfully thousands of times each year to treat sudden cardiac arrest. Automated external defibrillators (AEDs) are found in public settings and increasingly in homes, airports and office buildings. More complex external defibrillators are used in hospitals by trained health care professionals.

Nearly 300,000 Americans collapse each year when the heart stops pumping blood to the body (sudden cardiac arrest). Those who experience the condition may die if normal rhythms are not restored quickly. Survival depends on a rapid sequence of rescue events that can include the successful delivery of a high-energy shock from an external defibrillator. During the past five years, the FDA’s Center for Devices and Radiological Health (CDRH) has received more than 28,000 medical device reports associated with the failures of external defibrillators and manufacturers conducted dozens of recalls involving hundreds of thousands of the devices. Many of the types of problems that CDRH has identified are preventable, correctable, and can impact patient safety. These problems include engineering design and manufacturing practices related to the adequate control of components bought from other suppliers.

“These devices play an important role in health care,” said CDRH Director Jeffrey Shuren, M.D. “The purpose of our initiative is to improve these technologies so we can save more lives.” As a part of a broad initiative, CDRH is taking steps to work with manufacturers, users and experts in the field to improve the engineering design and manufacturing practices of these devices, and facilitate the development of their next generation.

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ABBOTT POINT OF CARE, INC., Princeton, New Jersey. I-Stat Accessory: GCX Mountable Downloader-Recharge accessory to the i-STAT Portable Clinical Analyzer (model300). Class III. Firm initiated recall ongoing. Firm notified users by letter dated date August 20, 2010. Volume in Commerce: 277 units. Reason: Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer. FDA recall #Z-2462-2010. FDA Enforcement Report, 11/10/10.

DRAGER MEDICAL SYSTEMS, INC., Telford, Pennsylvania, Anesthesia Machines: 1) Fabius GS Anesthesia Machine; 2) Fabius Tiro Anesthesia Machines. Class II. Firm initiated recall ongoing. Firm notified users by letters dated August 2010. Volume in Commerce: 203 power cords. Reason: Potential failures to Electri-Cord Manufacturing AC power cord. FDA recalls #Z-2478/2479-2010. FDA Enforcement Report, 11/10/10

HOLOGIC, INC., Indianapolis, Indiana. Handpiece: Suros ATEC 0912-20 Breast biopsy and Excision System Handpiece, REF ATEC0912-12. Class II. Firm initiated recall ongoing. Firm notified users by letters dated August, 11, 2010. Volume in Commerce: 990 units. Reason: The firm received a customer complaint that the device labeled as ATEC 0912-12 was actually ATEC 0912-20. FDA recall #Z-2285-2010. FDA Enforcement Report, 11/10/10

HOSPIRA, INC., Lake Forest, Illinois: Manufacturer: Hospira Holdings de, Costa Rica, LTD, La Aurora de Heredia, Costa Rico. Gemstar IV Pump Sets: Seven list numbers, all latex free: # s 12640-01, 13261-01, 13263-01, 13273-01, 19680-28, 20634-01, & 20635-01. Class II. Firm initiated recall ongoing. Firm notified users by letter dated August 12, 2010. Volume in Commerce: 340,824 units. Reason: Under delivery during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication. FDA recalls #Z-2627/2633-2010. FDA Enforcement Report, 11/10/10.

INTEGRA LIFESCIENCES CORP., Plainsboro, New Jersey: Manufacturer: LifeSciences (Ireland) Limited, Sragh, Tullamore, Co, Ireland. Surgical Aspirator System: 1) CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1; 2) CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT2. Class II. Firm initiated recall ongoing. Firm notified users by letter dated July 29, 2010. Volume in Commerce: 35 units. Reason: A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned off. This may result in excess aspiration that requires medical intervention. FDA recalls #Z-2637/2638-2010. FDA Enforcement Report, 11/10/10.

PHILIPS HEALTHCARE, INC., Andover, Massachusetts: Manufacturer: Philips Medzin Systems Boblingen Gmbh, Boblingen, Germany. Monitors: 1) M3002A IntelliVue X2; 2) M8102A IntelliVue MP2 Model. Class II. Firm initiated recall ongoing. Firm notified users by letters dated August 26, 2010. Volume in Commerce: 22,813 units. Reason: Speakers on the Philips IntelliVue X2 monitors may fail, causing absence of an audible alarm and delaying patient treatment. FDA recalls #Z-2625/2626-2010. FDA Enforcement Report, 11/10/10.

PRIDE MOBILITY PRODUCTS, CORP., Exeter Pennsylvania. Powered Wheelchair: 1) Jazzy Select with XLR Port Harness; 2) Jazzy Select 6 with XLR Port Harness. Class II. Firm initiated recall ongoing. Firm notified users by letters dated February 1, 2010. Volume in Commerce: 100,636 units. Reason: Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. This can cause the wire connector and/or the wire itself to be pulled or pinched which can lead to a short or open circuit. FDA recalls #Z-2618/2619-2010. FDA Enforcement Report, 11/10/10.

STRYKER ENDOSCOPY, INC., San Jose, California. Scope Washer Warmer: Pre-warms endoscopes to body temperature, keeping them fog-free- disposable. Class II. Firm initiated recall ongoing. Firm notified users by letters dated June 21, 2010. Volume in Commerce: 191,855 units. Reason: Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility. FDA recall #Z-2622-2010. FDA Enforcement Report, 11/10/10.

TELEX MEDICAL, Durham, North Carolina. Weck IMA/ENT Blade Electrode. Class II. Firm initiated recall ongoing. Firm notified users by letter dated July 30, 2010. Volume in Commerce: 190,344 units. Reason: Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes. FDA recall #Z-2584-2010. FDA Enforcement Report, 11/10/10.