Medical Malpractice

• Defective Infusion Pumps Seized By Federal Agents

  Jamie Sheller | August 29, 2006 1:49 PM | 0 CommentsPhiladelphia, PA

  A supply of Alaris infusion pumps, worth approximately 1.8 million dollars, was seized by United States Marshals. The seizure involved several models of Alaris infusion pumps, and took place at the company's manufacturing plant in San Diego, California. A design defect called "key bounce" could cause the infusion pumps to deliver an over-infusion of medication, which may result in injury or...

• Recall of Another External Defibrillator

  Jamie Sheller | July 11, 2006 8:11 AM | 0 CommentsPhiladelphia, PA

  The FDA has issued a Class 1 recall of Welch Allyn PIC 50 Automated External Defibrillators, manufactured between March 2002 and October 2004. The device may delay or fail to resuscitate the patient. This failure is caused by an eletrical contact problem. During this failure, the device may display various error messages including the "Defib Comm" message.

• Manufacturing Deficiencies With Baxter's Infusion Pump

  Jamie Sheller | July 05, 2006 8:40 AM | 0 CommentsPhiladelphia, PA

  Baxter Healthcare Corp. (Baxter) has stopped production and distribution of its Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until manufacturing deficiencies are corrected. This action was announced by the FDA and was part of a consent decree signed by Baxter and its CEO and Corporate Vice President. Patients use infusion pumps to control delivery of...

• Safety Alert Issued For More Boston Scientific Heart Devices

  Jamie Sheller | June 27, 2006 8:27 AM | 0 CommentsPhiladelphia, PA

  Boston Scientific has announced a safety alert regarding some of its pacemakers and cardiac defibrillators. "The specific subset of devices includes INSIGNIA and NEXUS pacemakers, CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM 2, VITALITY, AND VITALITY 2 implantable cardioverter defibrillators." An identified issue with a low-voltage capacitor may cause loss of...

• Recall of External Defibrillator

  Jamie Sheller | June 19, 2006 9:46 AM | 0 CommentsPhiladelphia, PA

  MRL, a division of Welch Allyn, is recalling about 500 of its model AED20 automatic external defibrillators. A faulty electrical connection could cause the device to malfunction and fail to resuscitate patients. For all customers of the recalled defibrillators, MRL will pay the costs to ship and replace the defective component. The FDA has determined that this action is a Class I recall,...

• New Warning About Defect In Guidant Heart Devices

  Jamie Sheller | May 17, 2006 8:33 AM | 0 CommentsPhiladelphia, PA

  Boston Scientific recently announced a new defect in Guidant heart defibrillators that may cause the devices to quit prematurely. The battery failure is due to a defective low-voltage capacitor. According to the company, the problem affects the following models: Vitality DS, Vitality AVT, Vitality 2, Contak Renewal 3 and 4, and Contak Renewal 4 AVT. The capacitor in question came from a...

• New Guidelines Recommended For Heart Device Industry

  Jamie Sheller | April 27, 2006 11:07 AM | 0 CommentsPhiladelphia, PA

  The Heart Rhythm Society, a group of electrophysiologists, has drafted some guidelines regarding pacemakers and implantable defibrillators. The guidelines were drafted after the society, FDA representatives and industry representatives participated in a two-day meeting last September. Included in the guidelines are recommendations for independent watchdog committees to monitor manufacturing...

• Ultilet Insulin Syringe Recalled

  Jamie Sheller | April 19, 2006 10:15 AM | 0 CommentsPhiladelphia, PA

  Boca Medical Products voluntarily recalled some of its insulin syringes because of possible bacterial contamination. A contaminated syringe poses a risk of local infection and also introduction of bacteria into a sterile vial of insulin. The specific syringe is Ultilet Insulin Syringe 30g 1/2cc (Lot # 5GEXI, NDC# - 08326-3002-50). The syringes were distributed in the following states: AL, AR,...

• Guidant Faced Internal Turmoil Over Defective Heart Devices

  Jamie Sheller | February 28, 2006 9:54 AM | 0 CommentsPhiladelphia, PA

  Newly released documents demonstrate turmoil inside Guidant Corporation while its heart devices came under scrutiny last year. The records include e-mail messages, transcripts, memos and notes. While Guidant's public message was upbeat and positive, the company's executives and sales representatives were alarmed about the scrutiny of defects in its defibrillators and pacemakers, and the company...

• Bidding War for Guidant Heats Up

  Jamie Sheller | January 20, 2006 7:28 AM | 0 CommentsPhiladelphia, PA

  After Guidant Corporation appeared ready to give its full support to latest bid from Johnson and Johnson, Boston Scientific raised its bid for Guidant, with help from Abbott Laboratories. The new offer, at $80 a share, quickly got Guidant to switch its support from the Johnson and Johnson proposal to Boston Scientific. The two companies have recently been in a bidding war for Guidant, which...