BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4190039 · Received October 21, 2014

    Report

    Report Number
    1416980-2014-36751
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    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 SUMMARY: THE EVALUATION OF THE RETURNED DEVICE IS COMPLETE. A VISUAL INSPECTION WAS PERFORMED AND FOUND A LOOSE COIL CAP AND MALFORMED HOUSING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE LOOSE COIL CAP WAS DETERMINED TO BE DUE TO THE MALFORMED HOUSING. THE CAUSE OF THE MALFORMED HOUSING COULD NOT BE DETERMINED. THIS ISSUE IS CURRENTLY BEING ADDRESSED THROUGH A CAPA. 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 COILED CAP OF A LARGE VOLUME INFUSOR WAS LOOSE. THIS WAS NOTED BEFORE PATIENT USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668687 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14E014

    Patients

    Seq Age Sex Outcome Treatment
    1