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Alaris Infusion Pumps

Alaris Infusion Pumps Side Effects Lawsuits | Side Effects: IV Overdose, Incorrect Dosage, Drug Overdose | Unregulated, Key Bounce, Incorrect Infusion Rate, Occurred FDA Violations

Alaris Infusion Pumps Side Effects May Lead To IV Drug Overdose Lawsuits

Alaris Infusion Pumps | Lawsuits, Lawyers | Side Effects: IV Overdose, Incorrect Dosage, Drug Overdose | Unregulated, Key Bounce, Incorrect Infusion Rate, Occurred FDA Violations

On Monday August 28, 2006, Cardinal Health Inc. proclaimed they were suspending the manufacturing, sales, and installations of their Alaris SE infusion pumps. This action was taken after U.S. regulators seized approximately 1,300 of the devices on August 25, 2006. U.S. marshals seized the products from Alaris' manufacturing facility in San Diego, California at the request of the FDA. The FDA said in a statement that the pumps might pose a potential risk towards patients.

Cardinal stated that a sensitive keypad on the systems posed a chance of overdose of the IV drugs. Infusion pumps are electronic devices used to manage the release of intravenous solutions or medications. Cardinal Health Inc. said it is presently testing a modification of the devices that would diminish the sensitivity of the keypad. The new modification would need to be approved by the FDA.

According to the FDA the keypads on the Alaris pumps are prone to key bounce, which takes place when a number pressed on the pump records twice, although the operator only pressed the key once. If key bounce does take place and is not identified during programming verification, it can result in an infusion rate of at least 10 times the intended rate, the agency said.

The Food & Drug Administration stated their inspectors reveled that Cardinal Health Inc. unsuccessful followed the agency's manufacturing regulations for medical devices. The FDA said Alaris had been issued warning letters in August 1998 and October 1999 outlining the violations and was given chances to fix the violations, but failed to take proper actions.

The suspended pumps are Cardinal's Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231.

Legal Help For Victims Affected By Alaris Infusion Pumps

If you or a loved one suffered injuries from a Alaris Infusion Pump, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).



 

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Alaris Pump Recall Update

Aug 4, 2009 | Parker Waichman LLP
CareFusion Corporation, which is expected to become a public company following its planned spin-off from Cardinal Health, just issued an update to its previously disclosed recall of the Alaris System, said the U.S. Food and Drug Administration (FDA). On June 12, 2009, the company sent an urgent Medical Device Recall Notification to customers of its Alaris® System addressing potential risks identified with the Alaris System. The affected devices have one or more failures associated with the...

Alaris Pump Modules Recalled by Cardinal Health Following Death Reports

Dec 27, 2007 | Parker Waichman LLP
Alaris Pump modules manufactured by Cardinal Health where recalled this week due to a defect in the pumps that could lead to over-infusion.   The company became aware of the defective medical devices following a review of customer complaints and service data. Cardinal Health received one report of an injury and two reports of patient deaths that may be associated with the defective Alaris Pump modules.The Alaris Pump module recall involves model 8100—formerly known as Medley...

Class 1 Recall: Cardinal Health Alaris SE Infusion Pumps

Sep 26, 2006 | www.fda.gov
Date Recall Initiated: August 10, 2006 Product: Alaris SE Infusion Pumps (formerly Signature Edition ® Infusion Pumps) model numbers 7000, 7100, 7107, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232. Use: These electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream. Recalling Firm:Cardinal Health10221 Wateridge CirSan Diego , CA...

Class 1 Recall: Cardinal Health Alaris SE Infusion Pumps

Sep 26, 2006 | www.fda.gov
Date Recall Initiated: August 10, 2006 Product: Alaris SE Infusion Pumps (formerly Signature Edition ® Infusion Pumps) model numbers 7000, 7100, 7107, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232. Use: These electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream. Recalling Firm:Cardinal Health10221 Wateridge CirSan Diego , CA...

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