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

Model Number	8120
Medical Device Problem Codes	Use of Device Problem (1670); Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported that "something is wrong" with the alaris devices.The customer provided the following information on 17 april 2026.A patient received "100 times" more than the prescribed dose of hydromorphone between (b)(6) 2026 and (b)(6) 2026 while the specific time of event was approximately 1615 on (b)(6) 2026.The patient received more narcotic medication than prescribed and was suspected to be an entry error.The medication was held for six hours, and the patient was heavily sedated for a period of two days.The customer also specified that they were not reporting a pump malfunction.The customer was requesting the following information from the investigation: "we need all manually entered pump changes for: medication type, infusion rate, volume and dose concentration, key entry for pca, clearing of volume infused, between (b)(6) 2026 and (b)(6) 2026".
Additional Manufacturer Narrative
Bd technical support troubleshoot with customer over the phone.A follow up report will be submitted once the failure investigation has been completed.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.

• Brand Name: ALARIS SYSTEM
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130-4386 ; 8586172000
• MDR Report Key: 25110220
• Report Number: 2016493-2026-26727
• Device Sequence Number: 10339276
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: (01)10885403812002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 8120
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2014
• 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: 8100
• Patient Sex: Unknown