BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3812077 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15488
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 14B043 WAS MANUFACTURED BETWEEN FEBRUARY 27, 2014 ¿ MARCH 1, 2014. EVALUATION: 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 RECEIVED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. A LEAK TEST WAS PERFORMED BY FILLING THE DEVICE WITH GREEN COLOR WATER. DURING FILLING A LEAK WAS OBSERVED AT THE FILL-PORT. THE CAUSE OF THE LEAK WAS DETERMINED TO BE GLASS FRAGMENTS MEASURING 0.2 MM AND 1.1 MM THAT WERE TRAPPED UNDER THE CHECK-BAND. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR ELASTOMERIC DEVICE LEAKED AT THE FILLING PORT DURING FILLING WITH AN UNKNOWN SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290204 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B043

    Patients

    Seq Age Sex Outcome Treatment
    1