Alaris Infusion Pumps Recall

The FDA initiated its most serious, Class 1, recall for the Alaris brand of intravenous, intra-arterial electronic infusion pumps.

Manufacturer Cardinal Health recalled the devices after noting problems that may result in insufficient dosing or overdosing and may cause serious injury or death.

The recall is for all Alaris System, Alaris Pump module 8100, and Alaris PC 8000 and 8015 units, formerly known as Medley PC units.

Risks with the pumps include:

* Failure of the Occlusion Warning Message to adequately guide users to clear blocked IV tubing, which could result in underinfusion
* Possible overinfusion, if warnings that the programmed infusion rate exceeds the volume of therapy in the pump are ignored and the pump injects the contents of the syringe into the patient
* Failure of the Electrostatic Discharge Protection Circuitry, resulting in an unresponsive keypad, key entries without key presses, or incorrect registering of key entries
* Failure of IV tubing, resulting in fluid entering the pumping mechanism and overinfusion of therapy

The pump recall started on June 12, 2009 when the company sent a mass mailing to all Alaris System customers explaining the device errors and precautionary measures that should be taken with the device, including how to reprogram the device to ensure proper use.