CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)

FDA device recall Z-1359-2020 · posted 2020-03-05 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

FRN

Quantity affected

870070

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,

Date initiated

2020-02-04

Date posted

2020-03-05

Location

San Diego, CA

Related 510(k) clearances