FDA Device

WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia.

Hazard

Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.

What You Should Do

Remedy

All customers were notified by letter on 06/17/2010, describing the affected product and advising them of the possible malfunctioning alarm in the case a user does not follow the instructions as specified in the Triton Operation Manual. The letter also reminded all users to follow the procedures in the IFUs. The firm stated that it was best if customers re-educated all nurses on the proper door closure procedure to help prevent the potential bypass issue from occurring. Attached to the letter were two pages explaining the proper process for closing the pump door. Follow-up phone calls were made to coordinate an upgrade to all affected pumps. Questions or concerns should be directed to Ross Kurz at 720-531-4933.

Products

WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia.
Brand
Walkmed Infusion LLC
UPC
Serial numbers: 1 thru 500, TR1041 through TR2559.

Units Affected

1565 pumps