BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ

    MDR report key: 2191881 · Received March 24, 2011

    Report

    Report Number
    2191881
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    A HOSPIRA SYMBIQ PUMP CAME TO BIOMED FROM SPD WITH A NOTE STATING 'ERROR'. I TURNED ON THE PUMP AND FOUND THAT IT HAD A WHITE SCREEN WITH: "DEVICE MALFUNCTION: SOFTWARE ERROR" DISPLAYED. PUMP CAN NOT BE RESET OR REPAIRED AT THE FACILITY. WILL HAVE TO BE SENT BACK TO HOSPIRA FOR REPAIR. NO FURTHER INFORMATION AS TO WHERE THE PUMP CAME FROM OR IF A PATIENT WAS INVOLVED DURING THE FAILURE.====================== MANUFACTURER RESPONSE FOR INFUSION PUMP, SYMBIQ======================SEND UNIT BACK IN FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ INFUSION PUMP FRN HOSPIRA SYMBIQ *

    Patients

    Seq Age Sex Outcome Treatment
    1 *