Alaris Pump Module Model 8100 recallZ-2736-2020 · CareFusion 303, Inc. · initiated Jun 30, 2020

Why it was recalled

Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.

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. Ensure back-up devices are readily available when infusing critical medications. 2. Follow the User Manual instructions on how to properly load the administration set into the Pump Module. 3. This issue will not cause a pump alarm so when beginning an infusion, and periodically during an infusion: a. Check the drip chambers for both primary and secondary infusions to ensure the drip rate correlates to the intended infusion rate. b. Know the expected duration of the infusion, and periodically check the amount of mediation/fluid remaining in the container. If the infusion seems to be running faster or slower than expected, immediately transfer the infusion to a different Pump Module. 4. If the pump module be dropped or severely jarred, immediately remove it from use and send it to biomedical engineering. Actions for Cleaning Personnel: During each cleaning open the door of each pump module and inspect the platen, hinges, and membrane frame for cracks or other damage. If damage is found, do not use the device and remove it from service and send to biomedical engineering. Actions for Biomedical Engineering: Expedite inspection. Verify the membrane frame assembly is not loose, and that the seal is not torn. Replace any platen or membrane frame assembly that is broken, cracked or damaged. If damage is found, do not use. Actions by Recalling Firm: Revised the Technical Service Manual and is offering a Medication Safety program. 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, [email protected]

Recall details

Recall number

Z-2736-2020

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

1093588

Product code

FRN

FDA submissions

K133532

Distribution

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

Product description

Alaris Pump Module Model 8100

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