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Health product recall

Alaris Pump Module Model 8100 – Intermittent motor stall during infusion

Starting date:
July 20, 2012
Posting date:
September 3, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-23839

Recalled Products

A. Alaris Pump Module Model 8100

Reason

The Alaris Pump Module Model 8100 manufactured between August 2010 and July 2011 may experience an intermittent motor stall during infusion. The investigation revealed that a mechanical binding within the mechanism assembly is resulting in a motor stall. When a motor stall occurs, the Alaris PC Unit and the Alaris Pump Module Display the Visual Error Code 242.4030 with an audible alarm and is followed by a termination of infusion.

Affected products

A. Alaris Pump Module Model 8100

Lot or serial number

> 10 Serial Numbers, contact manufacturer

Model or catalog number

8100LVP

Companies
Manufacturer
Carefusion 303, Inc.