BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 4834546 · Received June 9, 2015

    Report

    Report Number
    2937457-2015-01133
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    April 27, 2015
    Report Date
    May 13, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    K935958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED ONCE THE CRIT-LINE BLOOD CHAMBER LOOSENED FROM THE ARTERIAL END OF THE DIALYZER. THE LEAK WAS VISUALLY OBSERVED TO BE BELOW THE WINGS OF THE PVC ADAPTOR AROUND THE THREADED AREA THAT CONNECTS TO THE DIALYZER. ESTIMATED BLOOD LOSS WAS LESS THAN 30CC. THE PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT COMPLETED TREATMENT. SAMPLE HAS NOT BEEN RETURNED TO MFR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372929 CRIT-LINE BLOOD CHAMBER KOC KOC FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS 2008T HEMODIALYSIS MACHINE