—#182143

Product

Alaris System PC Unit Model 8000 modular infusion pump and monitoring system

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K133532
Affected lot / code info: All serial numbers

Why it was recalled

If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 06/30/2020, Urgent Medical Device Recall Notifications were mailed to Directors of Biomedical Engineering, Nursing, Risk Management, Environmental Services. Actions for Clinical Users: This situation only occurs when the device is running on battery power. 1. If this issue occurs, immediately plug the PC unit into AC power and restart the infusions. 2. Obtain a replacement PC unit as soon as possible. 3. Ensure back-up devices are readily available when infusing critical medications. Please also ensure that you have back-up monitoring devices (e.g., EtCO2, SpO2) that are critically important to the patient's care. 4. Complete and return the Customer Response Card. Actions for Cleaning Personnel: Inspect all PC unit batteries for missing screws and washers during cleaning. Should missing screws or washers be identified, send PC unit to Biomedical Engineering for repair. Expedite the inspection of all PC unit batteries for loose or missing screws and washers. If loose or missing screws and washers are identified, please replace them and torque any loose screws or washers to 6 in/lb and perform battery conditioning. See Service Bulletin 592A. Contact recalling firm at 1-800- 482-4822 to order a package of screws and washers. Battery should be replaced every two years by qualified service personnel using authorized batteries. Actions by Recalling Firm: Battery Pack Assembly procedure was revised to add clarity for reassembly of the battery, including proper use of screws and washers. Updated Service Bulletin to be provided in August 2020. An initial quantity of replacement screws and washers will be provided for use. Future orders for replacement batteries will include screws and washers System rental providers, please provide a copy of this letter and enclosures to your customers who are renting affected devices. Recall resources/customer support: www.bd.com/alaris-system-hardware-recall Questions - Recall Support Center: 858-617-1316, GMB-Ala

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: U.S.: CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, KS, MN, MI, WA, UT, MD, TN, CO, NJ, NE, ND, WV, KY, IA, MS, AL, DE, AK, VA, OK, NM, GA, CT, SD, NV, ID, MT, ME, VT, WY, NH, MP, DC, GU, PR, AS, RI. O.U.S.: TR, QA, CA, AE, KW, MX, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, BH

Timeline

Recall initiated: 2020-06-30
Posted by FDA: 2020-08-06
Terminated: 2024-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182143. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.