The FDA today issued 2 recall notices related to CareFusion‘s Alaris pumps, including 1 to CareFusion over alarm issues and another to Elite Biomedical Solutions over a flaw in a replacement frame membrane for the drug pumps.
The FDA has labeled the recalls as a Class I, the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
CareFusion received 108 reports of an error in which a visual and audible alarm that causes the Alaris pump to stop supplying infusion to the patient, according to the FDA.
Even if the error is cleared, the pump does not respond to key presses until the unit is completely disconnected and reconnected to the computer unit used to program, monitor and provide power to the pump, the federal watchdog said.
Failures in the syringe pump may cause delays or interruptions of therapy and can lead to serious injury or death, the FDA said. So far, CareFusion has not received any reports of permanent injury or death.
A total of 6,458 Alaris syringe pumps, model number 8110, are affected by the recall. The recalled pumps were manufactured between March 2014 and September 2014 and distributed between March 17, 2014 and September 30, 2014. All units recalled were distributed within the U.S.
CareFusion began notifying customers of the issue July 20, saying the company would initiate repairs on the units within 60 days and advising users to sequester the pumps and use alternate units.
A 2nd Alaris recall was issued involving Elite Biomedical Solutions’ Alaris medley large volume pump frame membrane, a replacement piece for a CareFusion Alaris pump. The frame membrane is a part of the Alaris pump that prevents fluids from leaking into internal components, according to the FDA.
Elite Biomedical Solutions said it discovered that use of the replacement frame membrane could lead to over or under infusion of fluids to the patient, with the potential to cause injury or death.
A total 1,502 units distributed within the U.S. are affected by the recall, manufactured between February 20, 2015 and April 21, 2015 and distributed between February 25, 2015 and May 8, 2015, the FDA said.
Elite Biomedical Solutions began contacting customers about the issue on May 21, urging customers to quarantine any indicated products and contact any patients the parts could have been distributed to.