The FDA issued a class 1 recall of CareFusion’s 303 Alaris Pump Module, Model 8100 to a large list of recently recalled CareFusion products.
The FDA’s announcement stated “potential for the pump module door keypad overlay to become loose, peel away or separate from the door assembly. This could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. When infusion stops, serious injury or death may result.”
“The pump module is intended for healthcare facilities that use infusion for the delivery of fluids, drugs, blood, and blood products using continuous or intermittent delivery through intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces routes of administration. The pump module is used for adults, children, and newborns,” according to the FDA news release.
Starting on July 20, 2102, each affected customer and distributor received an URGENT: Medical Device Recall Notification letter, FAQs, Summary of Affected Units and Response Card by overnight courier service. Customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation.
A listing of affected serial numbers are available on the company Web site.
CareFusion will follow-up within 60 days of receiving the letter with a telephone call to schedule a visit to replace the door assembly on their affected pump module.
Earlier this month the FDA announced a class 1 recall of another CareFusion pump, the Alaris PC Unit, Model 8015, part of the Alaris electronic infusion pump, citing a malfunction in its power supply board.
In June, the company issued an update reminding healthcare providers of its class 1 voluntary recall of its AirLife Infant Breathing Circuit, initiated in May.
In addition, in February 2012, the FDA initiated a class 1 recall for a CareFusion brain mapping device because of software malfunctions and a short circuit that can lead to tissue resection errors in patients undergoing surgery for seizures or tumors.
the agency warned that the device’s NicoletOne software with cortical stimulator license incorrectly indicates that stimulation is delivered to a different electrode than the one selected.
It also warned that a short circuit may develop between the Nicolet cortical stimulator control unit and the Nicolet C64 stimulus switching unit amplifier.
In December 2011, the FDA also announced a class 1 recall of CareFusion AVEA ventilators. The affected ventilators may develop a failure mode over a period of time, where the ventilator activates a false “extended high peak” (peak cycling respiratory pressure) alarm, opens the safety valve (by design), and stops ventilating.