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Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem

Mon, 11/08/2010 - 5:30am
U.S. Food & Drug Administration

AUDIENCE: Risk Manager, Patient

ISSUE: WalkMed Infusion LLC notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500 and serial numbers TR1401 through TR 2559, manufactured and sold before June 2010. If the pump door is not closed and latched per the instructions for use located on the side of the pump and in the operator manual, the pump door open alarm may not alert the user to this condition. It is then possible for the pump mechanism not to be engaged and a gravity feed flow condition to exist if the pump operator has not checked tube set for flow prior to starting the pump. This could result in over infusion of medication.

BACKGROUND: WalkMed Infusion has notified its distributors and customers by phone and e-mail and has begun the upgrade of all recalled products.

RECOMMENDATION: Consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[11/05/2010 - Press Release - WalkMed Infusion LLC]

    

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