BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMEPUMP C-SERIES

    MDR report key: 21200982 · Received January 21, 2025

    Report

    Report Number
    MW5165001
    Event Type
    Other
    Date Received
    January 21, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 15, 2025
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ELASTOMERIC PUMP DID NOT INFUSE CHEMOTHERAPY AS EXPECTED. PATIENT NOTICED THAT AFTER 48 HOUR PERIOD BALLOON HAD NOT DEFLATED. RETURNED DEVICE TO CLINICAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842162 HOMEPUMP C-SERIES PUMP, INFUSION, ELASTOMERIC MEB AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) 30226262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown