The recall includes the serial numbers 001 through 500 and serial numbers TR1401 through TR 2559 manufactured and sold before June 2010.
The firm voluntarily recalled the products after learning of the potential that the door open alarm might not function in certain door open positions. FDA has been apprised of this action.
No injuries have been reported to date and no reports of this issue have been received from field use. The issue was found internally by WalkMed Infusion. The condition has been found on some, but not all pumps in these serial number ranges and results from variability in the door open sensor mechanism. 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. If the instructions for use on the side of the pump and in the operator manual for set up and tube set placement are followed, gravity feed flow will not occur from this condition.
The Triton Pole Mount Infusion Pump was distributed nationwide to eight customers or distributors.