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U.S. Department of Health and Human Services

Class 1 Device Recall CareFusion Alaris Syringe Module, Model 8110

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  Class 1 Device Recall CareFusion Alaris Syringe Module, Model 8110 see related information
Date Initiated by Firm February 04, 2020
Create Date March 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-1361-2020
Recall Event ID 84579
510(K)Number K051641  K012383  
Product Classification Pump, infusion - Product Code FRN
Product CareFusion Alaris Syringe Module, Model 8110
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
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 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, these recall notifications were mailed to customers via 2-day delivery. 1) Software Errors related to System Error 255-XX-XXX: If two functions are selected in rapid succession or if not following typical workflows, System Error Code 255-XX-XXX may occur resulting in non-silenceable high priority alarms with flashing red status indicator lights. Modules will continue but programmed settings cannot be edited; may result in delayed start. Actions for Clinical Users: If the error occurs while you are 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. If editing of programmed settings of the critical medications is necessary, or if your infusion can be safely stopped, then power down the PC unit by pressing the SYSTEM ON key, indicated by a red, flashing arrow. Restart the device by pressing the SYSTEM ON key, program the pump as appropriate. Infusions are not restorable and will require reprogramming. If the System Error returns, power down the PC unit and replace it immediately. Return the PC unit to your Biomedical Engineering department for troubleshooting and log retrieval. Actions by Firm: If you have a PC unit with this System Error, please contact Customer Advocacy. 2) KVO Rate Not Available When Using Delay Options Programming: Actions for Clinical Users: a. For software versions 9.19 and prior: Set a Callback alert of "After" or "Before and After" to receive an End of Infusion alarm. b. For software version 9.33 and later: No action is required for an End of Infusion alarm. There is an Infusion Complete alarm at the end of the delayed infusion, but there is no KVO rate. c. For
Quantity in Commerce 114835
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

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.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = ALARIS MEDICAL SYSTEMS, INC.
510(K)s with Product Code = FRN and Original Applicant = CARDINAL HEALTH, ALARIS PRODUCTS
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