BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR SP INFUSION

    MDR report key: 3955439 · Received June 12, 2014

    Report

    Report Number
    9615050-2014-03963
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    Z1170-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE WOULD NOT POWER ON. THIS WAS DUE TO CORROSION CAUSED BY AA BATTERY LEAKAGE FOUND IN THE BATTERY COMPARTMENT AND ON THE MIDDLE CIRCUIT BOARD. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER BY THE CUSTOMER CONTACT WHO REQUESTED A YEARLY MAINTENANCE AND CALIBRATION. THERE WAS NO INDICATION OF A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING BATTERY LEAKAGE WAS FOUND IN THE BATTERY COMPARTMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347127 GEMSTAR SP INFUSION 80FRN FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1