BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCONCENTRATOR 20

    MDR report key: 4944836 · Received July 28, 2015

    Report

    Report Number
    8010762-2015-00028
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    January 3, 2014
    Report Date
    January 7, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KDI
    PMA / PMN Number
    K123290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK TESTING WAS PERFORMED ON THE RETURNED SAMPLE BY THE MANUFACTURER (B)(4) AND IT WAS DETERMINED THAT THE FIBERS WERE TORN DUE TO BEING EXERTED TO EITHER HIGH FLUID FLOW OR PRESSURE. THE FAILURE WAS NOT REPRODUCIBLE IN THE LABORATORY WHEN PRESSURE TESTING WITH NORMAL TREATMENT CONDITIONS WAS CONDUCTED ON SAMPLES FROM A PRODUCTION LOT. REFERENCE COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014 AT (B)(6) IT WAS REPORTED THAT THERE WAS BLOOD LEAKAGE AT THE OUTLET OF THE FILTER OF THE HEMOCONCENTRATOR BC 20 PLUS FROM LOT NUMBER 92116861. THERE WERE 5 OTHER DEVICES FROM THIS LOT REPORTED TO HAVE THE SAME PROBLEM WHICH ARE BEING SUBMITTED IN THE SEPARATE MEDWATCH REPORTS (8010762-2015-00636, 8010762-2015-00637, 8010762-2015-00638, 8010762-2015-00639, 8010762-2015-00640). REFERENCE COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490972 HEMOCONCENTRATOR 20 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MAQUET CARDIOPULMONARY AG BC 20 PLUS HEMOCONCENTRATOR 92116861

    Patients

    Seq Age Sex Outcome Treatment
    1