BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERFIFUSE

    MDR report key: 43934 · Received October 21, 1996

    Report

    Report Number
    MW1010113
    Event Type
    Malfunction
    Date Received
    October 21, 1996
    Date of Event
    July 28, 1996
    Report Date
    October 4, 1996
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS STARTED ON HEPARIN AT HOME FOR A DVT. THE PUMP DID NOT INFUSE PROPERLY. THE RES VOL WAS NOT DECREASING. THE USER COULD NOT GET THE PUMP TO RUN AFTER CHECKING THE BATTERIES AND TRYING TO ADJUST THE PUMP MANY DIFFERENT WAYS. THE PT DID NOT RECEIVE APPROX 3 HRS OF INFSUION. THE PT WAS CHANGED TO A DIFFERENT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERFIFUSE INFUSION PUMP FRN BLOCK MEDICAL, INC. VERIFUSE *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR