Nationwide recall of Triton infusion pump
WalkMed Infusion of Englewood, CO, is initiating a nationwide recall of a total of 2,018 Triton Pole Mount Infusion Pumps. The pumps have been found to possibly have a problem with the pump door open alarm, which potentially could result in over infusion of medication.
The recall includes the serial numbers 001 through 500 and serial numbers TR1401 through TR 2559 manufactured and sold before June 2010. Consumers who have Triton Pole Mount Infusion Pumps that are being recalled should return the pump to the manufacturer. The Food and Drug Administration (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 on the side of the pump and in the operator manual, the pump door open alarm might 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.
WalkMed Infusion has notified its distributors and customers by phone and e-mail and has begun the upgrade of all recalled products. Five of the eight distributors/customers have had their pumps upgraded.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Online: www.fda.gov/medwatch/report.htm. Regular mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane Rockville, MD 20857. Fax: (800) FDA-0178.