BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 1884275 · Received October 27, 2010

    Report

    Report Number
    6000001-2010-04552
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A VISUAL EXAMINATION WAS PERFORMED ON THE ACTUAL DEVICE. THE REPORTED CONDITION WAS CONFIRMED WITH DEVICE'S TUBING BEING BROKEN AT ITS JUNCTION WITH THE LUER. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR THAT HAD A LEAK IN THE OVERPOUCH. THE CONNECTION PORT CAME AWAY FROM THE LINE. THE DEVICE WAS FILLED WITH A 240ML SOLUTION OF FLUCLOXACILLIN AND 0.9% SODIUM CHLORIDE. THERE IS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV10, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10F068

    Patients

    Seq Age Sex Outcome Treatment
    1