BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3841409 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17460
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED BETWEEN JUNE 7, 2013 ¿ JUNE 10, 2013. EVALUATION SUMMARY: DURING EVALUATION OF THE UNIT FLUID WAS VISUALLY OBSERVED INSIDE THE HOUSING. A FUNCTIONAL TEST WAS PERFORMED, AND AFTER FILL, THE LEAK WAS VISUALLY OBSERVED AT THE WELDED AREA OF THE VOLUME INDICATOR PORT LOCATED INSIDE THE HOUSING. THE CAUSE COULD NOT BE DETERMINED. A CAPA HAS BEEN INITIATED TO INVESTIGATE THE LEAK. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED BETWEEN JUNE 7, 2013 ¿ JUNE 10, 2013. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED TWO DAY INFUSOR, LEAKAGE WAS FOUND AT THE WELDED AREA OF THE VOLUME INDICATOR PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318273 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION 13F012

    Patients

    Seq Age Sex Outcome Treatment
    1