Recall Z-1362-2020 ยท FRN Pump, Infusion
CareFusion 303, Inc.
CareFusion Alaris PCA Module, Model 8120
| Date | Mar 5, 2020 (initiated Feb 4, 2020) |
| Status | Open, Classified |
| 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 administeri |
| 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 |
| FDA record | Open on fda.gov |