FDA Recall Terminated

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.

Recall: Z-0307-2011 · Initiated June 17, 2010

Recall

Recall Number
Z-0307-2011
Event Number
56750
Firm
Walkmed Infusion LLC
FEI Number
3000204189
Product Code
FRN
Status
Terminated
Root Cause
Device Design
Initiated
June 17, 2010
Posted
November 5, 2010
Terminated
March 14, 2012
Address
96 Inverness Dr E, Ste N, Centennial, CO, 80112-5311

Description

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.

Reason

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

Action

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.

Distribution

Nationwide Distribution -- AL, CA, FL, and PA.

Quantity

1565 pumps