BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3161883 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14932
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. BACKFLOW WAS OBSERVED IN THE FILL PORT OF THE DEVICE DURING FLOW TESTING. VISUAL INSPECTION REVEALED THAT THE CAUSE OF THE BACKFLOW WAS A GLASS FRAGMENT UNDER THE CHECK-BAND OF THE DEVICE. THE CAUSE WAS DETERMINED TO BE USE ERROR SINCE THE GLASS FRAGMENT WAS THE RESULT OF THE DEVICE BEING FILLED WITHOUT A FILTER. IT IS RECOMMENDED IN THE DEVICE INSTRUCTIONS THAT THE DEVICE BE FILLED WITH A FILTER. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BACKFLOW CONDITION WAS OBSERVED WHILE FILLING AN INFUSOR SV2.5 DEVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263150 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12J071

    Patients

    Seq Age Sex Outcome Treatment
    1