BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSIFUSER ELASTOMERIC PUMP

    MDR report key: 7925990 · Received October 1, 2018

    Report

    Report Number
    MW5080251
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    September 28, 2018
    Report Date
    September 28, 2018
    Manufacturer
    GRIFOLS USA INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    GRIFOLS DOSIFUSER 46 HOUR PUMP FAILED TO INFUSE MEDICATION IN REQUIRED TIME. CONTACT 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765076 DOSIFUSER ELASTOMERIC PUMP PUMP INFUSION ELASTOMERIC MEB GRIFOLS USA INC. 180931L

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other