Recalls / —

—#184542

Product

Infusion Pump

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K042121, K133801, K173084

Affected lot / code info

Infusion Pump Product codes: 35700ABB, 35700BAX, and 35700BAX2  Battery codes: 35083, 35162, 35195, and 35724.  Infusion Pump Product codes: 35700ABB, 35700BAX, 35700BAX2 3570009  Battery codes: 35223 and 36010

Why it was recalled

Battery performance issues related to prolonged storage.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

1. If your facility is currently installing or planning to install new pumps and batteries that are currently in storage, please contact Baxter Technical Assistance at 800 356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time, for further instructions. The duration and conditions under which the new batteries have been stored will help determine whether battery damage due to depletion is likely. 2. For facilities currently using Spectrum pumps: If you are not experiencing recurrent battery alerts/alarms, continue using the Spectrum battery modules as indicated. If you are experiencing recurrent battery alerts/alarms, please operate your pumps on AC power and contact Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time. 3.Baxter is advising all customers who plan prolonged storage of Spectrum pumps and batteries to ensure the following: Batteries are charged to 2 or 3 bars prior to storage (do not fully charge); Batteries are stored between -10 and +35 degrees C (14 and 95 degrees F); Batteries are removed from the pump and stored independent of the pumps; and Batteries are recharged every six months while in storage. Not following these storage instructions can result in battery damage and/or reduced capacity and life of the battery. 4. The Spectrum Installation & Maintenance Guide/Service Manual, which can be accessed at https://service.baxter.com/tsportal/, describes a Battery Life Test that can be used to test for battery damage due to depletion. This test is recommended as part of routine maintenance. 5. Customers experiencing recurrent battery alerts/alarms should follow the instructions described in step 2 above. Do not attempt to resolve this issue by performing the battery recovery as described in the Technical Service Bulletins below. The battery recovery process is intended to recover a battery locked in a low c

Recalling firm

Firm

Baxter Healthcare Corporation

Address

711 Park Ave, Medina, New York 14103-1036

Distribution

Distribution pattern

Domestic Distribution: ST, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico. International Distribution: Canada, Barbados, Bermuda, St. Thomas, Guyana, Trinidad and Tobago, Jamaica and Nassau Bahamas.

Timeline

Recall initiated

2021-01-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #184542. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.