CareFusion 303, Inc.: CareFusion Alaris PCA Module, Model 8120

Recall number

Z-1362-2020

Recalling firm

CareFusion 303, Inc.

Product

CareFusion Alaris PCA Module, Model 8120

Status

Open, Classified

Initiated

2020-02-04

Posted

2020-03-05

Terminated

not on file

Reason

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

Root cause

Device Design

Action

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.

Quantity

83015

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.

Lot, serial or model codes

Software versions 12.1.0, and 9.33 and prior

510(k) numbers

["K012383","K051641"]

PMA numbers

not on file

Product code

FRN

Firm FEI

2016493

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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