By Cole Petrochko, Staff Writer, MedPage Today
Published: November 30, 2010
WASHINGTON — The FDA has issued an update to its class I recall of a pole-mounted infusion pump — recommending that users double-check and tug the pump’s door latch to make sure the door is securely closed to prevent the free flow of therapy.
The agency explained that the Triton Pole Mount Infusion Pump’s open door alarm may fail to warn that the door is not tightly closed, which may lead to free flow of infusion therapy — resulting in over-delivery of therapy and possibly serious injury or death, the FDA said in its recall update.
In an earlier statement , device manufacturer WalkMed Infusion noted that the infusion pump did not prompt users to follow proper door closure instructions printed on the unit or require visual inspection of the flow tube for free flow conditions.
On its website, the FDA said that if use of the recalled device could not be avoided, users should physically tug on the infusion pump door latch to ensure the door is tightly closed — and visually inspect the flow tube.
WalkMed offered to swap the recalled units for upgraded infusion pumps with properly-functioning open door alarms, the statement said.
The recalled Triton Pole Mount Infusion Pump units include serial numbers 001 to 500 and TR1401 to TR2559. The affected infusion pumps were manufactured and sold before June 2010, the statement said.
FDA class I recalls involve products that may reasonably cause serious injury or death with use.
WalkMed Infusion is headquartered in Englewood, Colo.