Alaris Infusion Pumps
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).