It seems like CareFusion has hardly been off our pages recently, this being the third time one of the company’s products has been the subject of a recall notice. On this occasion it’s the CareFusion 303, Alaris Pump Module, Model 8100 (formerly Medley Pump Module), which is the subject of an FDA Class 1 recall because of a risk that its door keypad overlay may separate from the keypad assembly. This product may cause serious adverse health consequences, including death.
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.
CaerFusion identified the potential problem when the pump module door keypad overlay was loose, peeled away, or separated 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, it could result in serious injury or death.
Customers have been contacted and asked to visually examine the pump module keypad overlay for obvious signs of overlay separation.
CareFusion has issued three of its own recall notices pertaining to the Alaris product, which can be found on the company’s alerts site, here. The first is as detailed above. The second relates to intermittent motor stalling on the same model and the third relates to the PC unit on its 8015 model which is reportedly throwing up error codes which can affect delivery of therapy at start-up.
Source: CareFusion, FDA