BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP INFUSION SET 0.2 MICRON FILTER

    MDR report key: 20323210 · Received September 26, 2024

    Report

    Report Number
    MW5160205
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 15, 2024
    Report Date
    September 23, 2024
    Manufacturer
    BD SWITZERLAND SARL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AMIODARONE TUBING DEFECTIVE. UNABLE TO PRIME IV (INTRAVENOUS) MEDICATION THROUGH TUBING IN-LINE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997592 ALARIS PUMP INFUSION SET 0.2 MICRON FILTER SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SARL 11532269 (10)24055895

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown