BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3093253 · Received May 5, 2013

    Report

    Report Number
    1416980-2013-11357
    Event Type
    Malfunction
    Date Received
    May 5, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED, WITH FLUID INSIDE OF THE RESERVOIR. A VISUAL EXAMINATION SHOWED NO SIGNS OF BLOCKAGE. A FUNCTIONAL FLOW TEST WAS PERFORMED AND FLOW CONTINUED FROM THE DEVICE WITHOUT STOPPING. THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED, NOR COULD A CAUSE BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR HAD EXPERIENCED A NO FLOW. THE PATIENT RECEIVED AN INFUSOR FILLED WITH MECLIZINE AND THE INFUSION WAS INITIATED AT THE PATIENT'S HOME. THE NEXT MORNING IT WAS IDENTIFIED THAT THE PUMP WAS NOT FLOWING. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195780 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11K008

    Patients

    Seq Age Sex Outcome Treatment
    1 MECLIZINE