Z-2736-2020Class I

Alaris Pump Module Model 8100

Name: Z-2736-2020 Alaris Pump Module Model 8100
Creator: CareFusion 303, Inc.
Published: 2020-06-30
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2020-06-30 / Terminated / root cause: design

FDA source

CareFusion 303, Inc. began a recall of Alaris Pump Module Model 8100 on 2020-06-30. FDA classified it as Class I and gives the reason as "Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2736-2020
Classification: Class I
Status: Terminated
Initiated: 2020-06-30
Posted: 2020-08-06
Terminated: 2024-04-23
Recalling firm: CareFusion 303, Inc
Product: Alaris Pump Module Model 8100
Product code: FRN Pump, Infusion
Reason for recall: Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
Root cause tag: design
FDA root cause: Device Design
Action: On 06/30/2020, Urgent Medical Device Recall Notifications were mailed to Directors of Biomedical Engineering, Nursing, Risk Management, Environmental Services. Actions for Clinical Users: 1. Ensure back-up devices are readily available when infusing critical medications. 2. Follow the User Manual instructions on how to properly load the administration set into the Pump Module. 3. This issue will not cause a pump alarm so when beginning an infusion, and periodically during an infusion: a. Check the drip chambers for both primary and secondary infusions to ensure the drip rate correlates to the intended infusion rate. b. Know the expected duration of the infusion, and periodically check the amount of mediation/fluid remaining in the container. If the infusion seems to be running faster or slower than expected, immediately transfer the infusion to a different Pump Module. 4. If the pump module be dropped or severely jarred, immediately remove it from use and send it to biomedical engineering. Actions for Cleaning Personnel: During each cleaning open the door of each pump module and inspect the platen, hinges, and membrane frame for cracks or other damage. If damage is found, do not use the device and remove it from service and send to biomedical engineering. Actions for Biomedical Engineering: Expedite inspection. Verify the membrane frame assembly is not loose, and that the seal is not torn. Replace any platen or membrane frame assembly that is broken, cracked or damaged. If damage is found, do not use. Actions by Recalling Firm: Revised the Technical Service Manual and is offering a Medication Safety program. System rental providers, please provide a copy of this letter and enclosures to your customers who are renting affected devices. Recall resources/customer support: www.bd.com/alaris-system-hardware-recall Questions - Recall Support Center: 858-617-1316, [email protected]
Quantity in commerce: 1093588
Distribution: US: CA, FL, IN, TX, NC, LA, SC, VA, PA, OK, AZ, IL, KY, UT, AL, GA, TN, MA, MI, OH, AK, OR, MS, CO, NY, WI, KS, MO, MD, NV, AR, AS, ID, VT, NE, NJ, DC, HI, CT, MT, WV, NH, WA, DE, ME, NM, MN, WY, IA, SD, ND, MP, PR, GU. OUS: NL, MX, AU, MY, NZ, ZA, GB, FR, CH, CN, SG, TW, CA, IL, KW, QA, DE, BH, IN, SA, GI, AE, PK, PH, BE
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2736-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2736-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06

Product code FRN

K133532Class IIAlaris System with Guardrails Suite MxCarefusion 303, Inc. / cleared 2014-08-21

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)