MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS SYSTEM; PUMP, INFUSION

Model Number	8015
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction

• 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 4386
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; 8586172000
• MDR Report Key: 25837681
• Report Number: 2016493-2026-46306
• Device Sequence Number: 18510888
• Product Code: FRN
• UDI-Device Identifier: 10885403801532
• UDI-Public: (01)10885403801532
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: Other
• Device Model Number: 8015
• Device Catalogue Number: 8015 ALARIS PCU 1.5 MODULE
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2020
• 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