—#111930

Product

Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K930459
Affected lot / code info: product codes 2M8170 and 2M8170R, all serial numbers

Why it was recalled

Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches .01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Baxter sent a Safety Alert letter on January 11, 2011 for the InfusO.R. Pump. Baxter expanded the scope of the recall to include the Mini-Infusers System and sent an Urgent Device Correction letter dated March 4, 2011, via First Class mail to all affected customers. The letters informed the customers that the Mini-Infusers use the same size battery and incorporate the same battery contact interface as the InfusOR pump, and that the same feature that inhibits electrical contact in over-the counter Energizer C size batteries may also be incorporated by other battery manufacturers. The customers were requested to verify that the InfusOR and Mini-Infuser will power-on before use; if the device does not power on, replace the batteries with a different brand of size C batteries and verify that the device will power-on before use; and to place a copy of the letter with each operator's manual for the InfusOR and Mini-Infuser System for future reference. For Technical questions call Baxter Global Technical Services at 1-800-843-7867. For question regarding this communication contact the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: 45,865 units

Timeline

Recall initiated: 2011-03-04
Posted by FDA: 2012-08-24
Terminated: 2012-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111930. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.