Z-1360-2020Class I

CareFusion Alaris Pump Module, Model 8100

Name: Z-1360-2020 CareFusion Alaris Pump Module, Model 8100
Creator: CareFusion 303, Inc.
Published: 2020-02-04
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2020-02-04 / Open, Classified / root cause: design

FDA source

CareFusion 303, Inc. began a recall of CareFusion Alaris Pump Module, Model 8100 on 2020-02-04. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1360-2020
Classification: Class I
Status: Open, Classified
Initiated: 2020-02-04
Posted: 2020-03-05
Recalling firm: CareFusion 303, Inc
Product: CareFusion Alaris Pump Module, Model 8100
Product code: FRN Pump, Infusion
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
Root cause tag: design
FDA 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 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.
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.
Product codes and lots: Software versions 12.1.0, and 9.33 and prior

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1360-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1359-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-03-11	2020-03-05
Z-1360-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-03-11	2020-03-05
Z-1361-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-03-11	2020-03-05
Z-1362-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-03-11	2020-03-05

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)