BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3203649 · Received July 3, 2013

    Report

    Report Number
    1416980-2013-17104
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE ROOT CAUSE OF THE LEAK WAS DETERMINED TO BE AN INADEQUATE WELD OF THE VOLUME INDICATOR AND THE PORT. IT WAS DETERMINED THAT THE ULTRASONIC WELD WAS NOT EXECUTED PROPERLY. THE WELDER SETTINGS WERE ADJUSTED TO ADDRESS THE PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION AND FUNCTIONAL LEAK TESTING OF THE SAMPLE REVEALED LEAKAGE, AT THE WELDED AREA OF THE VOLUME INDICATOR PORT. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR HAD LEAKED AFTER FILLING. THE DEVICE WAS FILLED WITH A SOLUTION OF DESFERAL AND THE LEAKAGE WAS NOTICED INSIDE OF THE HOUSING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304338 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13A063

    Patients

    Seq Age Sex Outcome Treatment
    1