Alaris System PC Unit Model 8015. modular infusion pump… recallZ-2741-2020 · CareFusion 303, Inc. · initiated Jun 30, 2020

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number

Z-2741-2020

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Jun 30, 2020

Posted by the FDA

Aug 6, 2020

Recalling firm

CareFusion 303, Inc.

Quantity

824277

Product code

FRN

FDA submissions

K133532

Distribution

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

Product description

Alaris System PC Unit Model 8015. modular infusion pump and monitoring system

Other devices under the same FDA submission

4 devices cleared under K133532 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Alaris™ Pump Module, Model 8100

  Carefusion 303, Inc. · Pump, infusion
  1 recall2 deaths5,636 reports
• Alaris 8975

  Carefusion 303, Inc. · Infusion safety management software
  169 reports
• Alaris 9601

  Carefusion 303, Inc. · Pump, infusion
  1 recall0 reports
• Alaris™ Syringe Module, Model 8110 8100

  Carefusion 303, Inc. · Pump, infusion
  14 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 85915).

• Z-2740-2020 · Terminated
  Alaris System PC Unit Model 8000 modular infusion pump and monitoring system