FDA ALERT

 

August 6, 2009

Alaris System (Cardinal Health): Class 1 recall due to potential for patients experiencing under- or over-infusion, which may result in serious injury or death

Audience: Hospital risk managers

FDA notified healthcare professionals of the Class 1 recall of various modules of Cardinal Health’s Alaris System, electronic infusion pumps that deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural, and other routes of administration. The firm initiated the recall after identifying five problems that affected the Alaris System, including failure of the occlusion warning message, syringe volume warning message, electrostatic discharge protection circuitry and fluid ingress tubing. It was determined that the five failures  may result in patients experiencing under- or over-infusion which may result in serious injury or death.The device is intended for use with adult and pediatric patients in hospitals including critical care units, emergency rooms, outpatient surgical centers, hospices, and nursing homes.

Read the complete MedWatch 2009 Safety summary, including a link to the FDA Recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174797.htm