BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR DOCK STA

    MDR report key: 2852814 · Received November 27, 2012

    Report

    Report Number
    3008785455-2012-00093
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    January 1, 2012
    Report Date
    September 14, 2012
    Manufacturer
    HOSPIRA, INC
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING THE DEVICE DID NOT DELIVER. DURING TESTING, A TEST PUMP AND TEST BOLUS CORD WERE CONNECTED TO THE DEVICE. THE PUMP DID NOT RECEIVE THE ELECTRICAL SIGNAL FROM THE DEVICE TO DELIVER A DOSE WHEN THE BOLUS BUTTON ON THE BOLUS CORD WAS PRESSED. THIS WAS DUE TO A MISSING BOLUS CORD CONTACT PIN ON THE DOCKING STATION. THE PROBABLE CAUSE FOR THE MISSING DOCKING STATION FEMALE CONTACT PIN WAS MISHANDLING OF THE DEVICE WHEN REMOVING THE BOLUS CORD FROM THE CONNECTION PORT. ACTIONS SUCH AS TWISTING OR ATTEMPT TO REMOVE AT AN EXTREME ANGLE MAY CAUSE THE DOCKING STATION FEMALE CONTACT PINS TO REMAIN.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE DID NOT DELIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTR DOCK STA 80FRN FRN HOSPIRA, INC 45879G1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA