BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD ALARIS PUMP INFUSION SET

    MDR report key: 24067369 · Received January 14, 2026

    Report

    Report Number
    MW5182214
    Event Type
    Death
    Date Received
    January 14, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 8, 2026
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD MAXZERO MICROBORE EXTENSION SET (REF: (B)(4) CONNECTED TO BD ALARIS PUMP INFUSION SET (REF: 24200007) CONNECTION POINT BETWEEN INFUSION SET AND EXTENSION SET WERE CONNECTED BUT LEAKED. PATIENT WAS UNDERGOING PROCEDURE REQUIRED ANTICOAGULATION MEDICATIONS UNCLEAR IF MEDICATIONS WERE FULLY INFUSED DUE TO LEAK. LAB VALUES ALIGN WITH INSUFFICIENT MEDICATION. PATIENT CLOTTED AND CODED. EXTENSIVE EFFORTS WERE UTILIZED BUT CARE WAS ULTIMATELY WITHDRAWN AND PATIENT PASSED. REFER TO ADD'L DOCUMENTS IN I2K. PT CODE: 1762. DEVICE CODE: 1250. REF REPORT: MW5182215.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128496 BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON AND COMPANY 25029194

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Death