—#181553

Product

Alaris System PC Unit Model 8015, a 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: During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. US and OUS serial numbers:

Why it was recalled

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

Root cause (FDA determination)

Device Design

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: 1.Inspect the IUI connectors on each PC unit and module prior to each use. DO NOT use a device with any damage, cracks, or surface contaminants (e.g., blue or green deposits, corrosion, cleaning residue deposition) on the IUI connectors, or with broken IUI connector pins. If damage, deposits, residue, or corrosion is noticed, take the device out of service and send the unit to Biomedical Engineering for repair. 2.Ensure back-up devices are readily available when infusing critical medications where interruptions could cause serious injury or death. Please also ensure that you have back-up monitoring devices (e.g., EtCO2, SpO2) that are critically important to the patient's care. 3.If the issue occurs, expedite a replacement PC unit and modules to restart the infusions and monitoring. 4. Complete and return the Customer Response Card. Actions for Device Cleaning Personnel: Firm will provide existing customers a System Cleaning Kit (including IUI connector covers and cleaning brushes), Service Bulletin 630, Best Practices for Cleaning, and an updated System User Manual Addendum in August 2020. Actions for Biomedical Engineering: Expedite inspection of the IUI connectors on each PC unit and module at your facility. In addition, develop a system to check the IUI connectors prior to returning a unit to use from storage or repair. Replace any IUI connector with damage, cracks, surface contaminants or contact or pin damage on the IUI connectors. System rental providers, please provide a copy of this letter and enclosures to your customers who are renting affected devices. Recall resources and customer support: www.bd.com/alaris-system-hardware-recall Additional questions contact Recall Support Center: 858-617-1316, GMB-AlarisMedSafetyProgram@bd.com

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and 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 #181553. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.