| Class 1 Device Recall CareFusion Alaris Pump Module, Model 8100 | |
Date Initiated by Firm | February 04, 2020 |
Date Posted | March 05, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1360-2020 |
Recall Event ID |
84579 |
510(K)Number | K012383 K051641 |
Product Classification |
Pump, infusion - Product Code FRN
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Product | CareFusion Alaris Pump Module, Model 8100 |
Code Information |
Software versions 12.1.0, and 9.33 and prior |
Recalling Firm/ Manufacturer |
CareFusion 303, Inc. 10020 Pacific Mesa Blvd San Diego CA 92121-4386
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Manufacturer 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 |
FDA Determined Cause 2 | 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.
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Quantity in Commerce | 1286898 |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = FRN 510(K)s with Product Code = FRN
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