—#179659

Product

CareFusion Alaris PCA Module, Model 8120

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K012383, K051641
Affected lot / code info: Software versions 12.1.0, and 9.33 and prior

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-02-04
Posted by FDA: 2020-03-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179659. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.