BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3802636 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14957
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: BAXTER RECEIVED ONE UNIT FOR EVALUATION. VISUAL INSPECTION FOUND NO EVIDENCE OF A DEFECT OR A BROKEN FILL-PORT. THE FILL-PORT WAS FUNCTIONALLY TESTED WITH A SYRINGE BY INSERTING IT INTO THE FILL-PORT AND TURNING CLOCKWISE, THEN IT WAS TURNED OPPOSITE DIRECTION TO REMOVE. THE SYRINGE TIP DID NOT BREAK OR STICK INSIDE THE FILL-PORT; THE REPORTED CONDITION WAS NOT VERIFIED. 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 THE FILLING PORT OF A SMALL VOLUME INFUSOR WAS BROKEN. THIS WAS NOTED DURING FILLING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281464 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13E058

    Patients

    Seq Age Sex Outcome Treatment
    1