BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 3969909 · Received April 30, 2014

    Report

    Report Number
    2937457-2014-00725
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    CONCORD MFT
    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

    THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED FROM THE TOP OF THE DIALYZER AND A CRACK WAS OBSERVED ON THE OUTER SEAM OF THE BLOOD CHAMBER OF THE CRIT-LINE DEVICE AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 500 CC. MED DOCTOR CAME TO THE UNIT AND EVALUATED THE PATIENT. PATIENT HAD NO ADVERSE EFFECTS AND REQUIRED NO MED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258865 CRIT-LINE BLOOD CHAMBER KOC CONCORD MFT 131203

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR FRESENIUS 2008K2 MACHINE