BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 33360 · Received June 11, 1996

    Report

    Report Number
    MW1009264
    Event Type
    Malfunction
    Date Received
    June 11, 1996
    Date of Event
    June 7, 1996
    Report Date
    June 7, 1996
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RPTR WAS FILLING THE PUMP WITH 100 ML OF DRUG/FLUID. WHEN RPTR WAS DONE, BEFORE RPTR COULD LUER-LOCK THE SYRINGE OFF OF THE PUMP, THE SYRINGE STARTED FILLING BACK UP. RPTR COULD NOT MAKE THE MEDICATION STAY IN THE PUMP WITHOUT BACKING UP INTO THE SYRINGE SINCE THERE WAS 100ML IN THE PUMP. RPTR WAS USING A 60ML SYRINGE. THERE WAS A BIG MESS BECAUSE THE EXCESS 40 ML OR SO SPEWED ALL OVER THE CLEAN ROOM AND HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE HOMEPUMP ELASTOMERIC INFUSION DEVICE MEB BLOCK MEDICAL, INC. E101000 51330

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other