MAUDE Adverse Event Report: CAREFUSION 303, INC. Alaris System; Pump, Infusion

Model Number	8110
Medical Device Problem Codes	Inaccurate Delivery (2339); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
Event or Problem Description
It was reported that the alaris syringe pump module administering continuous alprostadil infusion repeatedly alarmed for ¿patient occlusion,¿ with inconsistent documented infusion volumes (0.06ml at 8pm, 0.09ml at 9pm, and a decreased volume of 0.08ml at 10pm), likely related to frequent interruptions from occlusion alarms on (b)(6) 2026.After switching to a different syringe pump, the infusion volumes were accurate.Biomed evaluated the returned syringe only (p119377), as the pcu and tubing were unavailable, and was able to replicate decreasing volume readings when occlusion alarms were cleared without resolving the occlusion.Customer reported "minor harm, as the patient may have received less alprostadil than what was tracked by the pump".No further information was made available.Customer biomed has performed investigation on the device.Pcu and lines were not able to be set aside.Customer able to replicate the decreasing volume when the pump occlusion alarm is cleared without clearing the occlusion.Devices will not be sent to bd for investigation.

• Brand Name: Alaris System
• Common Device Name: Pump, Infusion
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CareFusion 303, INC.; 10020 pacific mesa blvd; san diego CA 92121 -438
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 25521552
• Report Number: 2016493-2026-37546
• Device Sequence Number: 16090295
• Product Code: FRN
• UDI-Device Identifier: 10885403811043
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K211218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8110
• Device Catalogue Number: 8110 Alaris Syringe Module
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Supplement Date Received by Manufacturer: 07/17/2026; 08/04/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/21/2026; 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015.
• Patient Sex: Unknown