BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 6192184 · Received December 20, 2016

    Report

    Report Number
    1416980-2016-18586
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 25, 2016
    Report Date
    December 20, 2016
    Manufacturer
    BAXTER HEALTHCARE- IRVINE
    Product Code
    MEB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURED MAY 21, 2015 ¿ MAY 22, 2015. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR HAD SOLUTION LEAKING FROM THE FILL PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839431 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE- IRVINE NA 15E042

    Patients

    Seq Age Sex Outcome Treatment
    1