CareFusion Alaris Pump Module Model 8100 Recalled due to Potential Motor Stalls

The FDA informs Risk Managers and Biomedical Engineering healthcare personnel that CareFusion Alaris Pump Module Model 8100 is recalled because there is a possibility of motor stall during infusion leading serious adverse events or death.

Background of CareFusion Alaris Pump Module Model 8100

Alaris Pump Module, Model 8100, by CareFusion 303 Inc, is part of the Alaris electronic infusion pump system. The system is used for the delivery of medications to patients through various acceptable routes of administration (i.e. intra-arterial, intravenous, etc.). It is used for newborns, children and adults.

FDA Alert on CareFusion Alaris Pump Module Model 8100

The FDA received reports of motor stalls during infusion with the CareFusion Alaris Pump Module, Model 8100. In this case, the visual error code 242.4030 appears with an audible alarm and the infusion stops. The consequences can be life-threatening especially in patients of high risk.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on CareFusion 303, Alaris Pump Module, Model 8100

“On July 20, 2012, CareFusion sent an urgent Medical Device Recall Notification to customers who purchased the Alaris Pump Module, model 8100. Customers were alerted to the potential risk to patient health caused by this failure and the letter advised clinicians to weigh the risk/benefit to patients before continuing to use this device. The following instructions were also communicated to customers:

• Facilities administering high risk infusions to high risk patients should consider using alternative devices, if available.
• If alternative devices are not available, facilities should consider having additional devices immediately available as backup.
• If a motor stall occurs with a pump, facilities should remove the pump module from use and contact the CareFusion Support Center.”

Contacting the FDA to report cases with CareFusion Alaris Pump Module Model 8100

In case of detection of adverse events or side effects related to the use of CareFusion Alaris Pump Module Model 8100, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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