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

Model Number	8015
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device washed out screen.There was patient involvement but unknown harm.
Additional Manufacturer Narrative
The actual date of event is unknown.A device history record, complaint history review, and risk review on failure modes are performed on each device with reportable malfunction(s) along with other methods of investigation as coded in section h6 of this mdr report.Investigation summary: the reported "display issue" event was confirmed and attributed to a defective logic board.An external and internal inspection of the suspect pcu was performed, and it was observed that the logic board was found to be functionally defective during internal inspection; however, no signs of physical damage were observed.A temporary replacement of the suspect pcu logic board was performed for testing purposes only.The returned suspect pcu passed all the pm (preventive maintenance) tests in alaris system maintenance (asm) (v12.5).The facility reported a display issue; no event date or time was provided.A review of the logs was performed, and no records related to the reported event were found.The last infusion recorded on the suspect pcu occurred on june 22, 2026, at 8:02 pm, during which a pump module with s/n 18187073 was programmed with a rate of 125 ml/h and a vtbi of 256.58 ml.Bd alaris¿ system with guardrails¿ suite mx (12.3) states: do not use a device that appears to be damaged.Send the device to biomedical engineering for repair.The device was in use for treatment purposes as intended per 21 cfr 820.198(d)(2).Root cause: the root cause of the reported 'display issue' event was determined and attributed to a defective logic board.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.

• 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): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50942091
• Report Number: 2016493-2026-67351
• Device Sequence Number: 10722616
• Product Code: FRN
• UDI-Device Identifier: 10885403519291
• UDI-Public: (01)10885403519291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 8015
• Device Catalogue Number: 8015 Alaris PCU 1.5 Module
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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
• Patient Sex: Unknown