BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SYMBIQ PUMP SET

    MDR report key: 1170772 · Received September 15, 2008

    Report

    Report Number
    9615050-2008-00277
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 25, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE SECONDARY TUBING SET WAS CONNECTED TO A PRIMARY TUBING SET AND WAS BEING USED FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED VOLUME OF MAGNESIUM SULFATE 1 GRAM/50ML IN 5% DEXTROSE FOR DURATION VIA A SYMBIQ PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED THE SECONDARY SOLUTION WAS FLOWING INTO THE PRIMARY TUBING SET AND SOLUTION CONTAINER. THE PUMP WAS REPROGRAMMED TO DELIVERY AT AN UNSPECIFIED RATE, AND THE THERAPY WAS RESUMED USING THE SAME TUBING SETS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSPECIFIED SYMBIQ PUMP SET ADMINISTRATION SET FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR LIFESHIELD SECONDARY PIGGYBACK SET, LIST #12667| LOT # UNK