CareFusion Alaris Pump Module, Model 8100 recallZ-1360-2020 · CareFusion 303, Inc. · initiated Feb 4, 2020

Why it was recalled

1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

FDA root cause category: Device Design

What the company is doing

On 02/04/20, Urgent Medical Device Recall Notifications were mailed and posted on the firm's website: www.bd.com/alaris-system-software-recall Two notifications were posted: 1) Software versions 9.33 and prior, and 2) software version 12.1.0. On 02/05/20. Recall letters can be found at https://www.bd.com/en-us/recall-notifications/detail-mms-20-1953 Firm will contact all customers to initiate the scheduling process for the software update. Before the update customers were asked to so the following: 1) Software Errors related to System Error 255-XX-XXX: If the error occurs while administering a critical medication(s), continue the infusion while you expedite a replacement pump if one is readily available, or restart and reprogram the PC unit. 2) KVO Rate Not Available When Using Delay Options Programming: For software versions 9.19 and prior: Set a Callback alert of "After" or "Before and After." For all software versions: Do not use Delay Options when a KVO rate is required. 3) Low Battery Alarm Failure: Whenever possible, keep the PC unit plugged into AC power. 4) Keep Vein Open (KVO) / End of Infusion Alarms Priority: Check and increase the audio volume. 5) Use Errors related to Custom Concentration Programming: Only use custom concentration when the medication label does not match any of the drug concentration selections on the programming screen. Customers can call the following phone numbers for assistance: Customer Advocacy at 888-812-3266, Clinical and Pharmacy Support Center at 858-617-1316, Recall Support Center 888-562-6018, and Technical Support 888-812-3229. On 07/29/21, Follow up Medical Device Recall Notifications were mailed to customers informing them that a new software version, v12.1.2., is available to remediate this recalls issues. Complete the acknowledgement form and contact the Recall Support Center to schedule remediation.

Recall details

Recall number

Z-1360-2020

Recall class

Class I (most serious)

Status

Open, Classified

Initiated by the company

Feb 4, 2020

Posted by the FDA

Mar 5, 2020

Recalling firm

CareFusion 303, Inc.

Quantity

1286898

Product code

FRN

FDA submissions

K051641, K012383

Distribution

Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ, MO, SD, UT, NM, MD, VT, MP, ND, AS; and countries of: Canada, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.

Product description

CareFusion Alaris Pump Module, Model 8100

Other devices under the same FDA submission

1 device cleared under K051641, K012383 — 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 8015

  Carefusion 303, Inc. · Pump, infusion
  2 recalls45 deaths148,093 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 84579).

• Z-1359-2020 · Open, Classified
  CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
• Z-1361-2020 · Open, Classified
  CareFusion Alaris Syringe Module, Model 8110
• Z-1362-2020 · Open, Classified
  CareFusion Alaris PCA Module, Model 8120