BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 4791461 · Received May 21, 2015

    Report

    Report Number
    2937457-2015-00943
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 6, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    K935958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 AT THE BOTTOM CONNECTION OF THE CRIT-LINE BLOOD CHAMBER THAT THREADS TO THE DIALYZER. THE LEAK WAS VISUALLY OBSERVED TO BE AN EXTERNAL LEAK BELOW THE WINGS OF THE PVC ADAPTER AROUND THE THREADED AREA THAT CONNECTS TO THE DIALYZER. ESTIMATED BLOOD LOSS WAS FROM 1 TO 10 CC. THE PT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PT COMPLETED TREATMENT. SAMPLE HAS NOT BEEN RETURNED TO MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331905 CRIT-LINE BLOOD CHAMBER KOC FRESENIUS MEDICAL CARE NORTH AMERICA 15011312

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS 2008K2 HEMODIALYSIS MACHINE