BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASEBY

    MDR report key: 496508 · Received November 12, 2003

    Report

    Report Number
    MW1030203
    Event Type
    Malfunction
    Date Received
    November 12, 2003
    Date of Event
    November 6, 2003
    Report Date
    November 7, 2003
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GRASEBY SYRINGE PUMP 3400 MALFUNCTIONED WHILE IN "BOLUS MODE" INFUSION SETTING DURING ADENOSINE STRESS TEST. CALCULATIONS AND SETTINGS ON PUMP WERE APPROPRIATE, BUT PUMP STARTED DELIVERING 2X THE PROPER DOSAGE - INFUSION WAS IMMEDIATELY STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRASEBY SYRINGE PUMP 3400 FRN GRASEBY MEDICAL LTD. 3400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other