Alaris EtCO2 Module Model 8300, a modular infusion pump and… recallZ-2721-2020 · CareFusion 303, Inc. · initiated Jun 30, 2020

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.

FDA root cause category: Device Design

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: 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]

Recall details

Recall number

Z-2721-2020

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

38982

Product code

FRN

FDA submissions

K133532

Distribution

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

Product description

Alaris EtCO2 Module Model 8300, a 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 85691).

• Z-2716-2020 · Terminated
  Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
• Z-2717-2020 · Terminated
  Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
• Z-2718-2020 · Terminated
  Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
• Z-2719-2020 · Terminated
  Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
• Z-2720-2020 · Terminated
  Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
• Z-2722-2020 · Terminated
  Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
• Z-2723-2020 · Terminated
  Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system