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

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.

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, [email protected]