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Syringe Pump Recall; Alarm Error May Cause Fatal Therapy Interruption


On February 10, 2017, CareFusion recalled the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. If the AIL sensor is faulty, the false alarm may be repeated and require the health care provider to clear the alarm to restart the infusion. Interruption of infusion could lead to serious adverse health consequences or death.

 

The Alaris Syringe Pump is an infusion pump that delivers fluids, such as nutrients, blood, and medications, into a patient’s body in controlled amounts. The syringe holds the solution, and the infusion tubing connects the syringe to the patient through intravenous or enteral access. The device, only used in hospitals and other health care facilities, is indicated for use in adults, pediatric patients, and infants and.

 

Affected syringe pumps have product numbers 147083-102 or 4900022. Products affected by this recall were manufactured and distributed between October 2011 and June 2015.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the FDA Safety Alert

 

See also the Recall.

 

See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment

 

See also Medical Law Perspectives, June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous 

 

 

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