BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 4791487 · Received May 21, 2015

    Report

    Report Number
    2937457-2015-00928
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 12, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    K935958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A PRODUCT RECALL HAS BEEN INITIATED BY THE MANUFACTURER AND THE REPORTED PRODUCT ISSUE IS BEING INVESTIGATED BY THE MANUFACTURER VIA A CAPA.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED AT THE CONNECTION OF THE CRIT-LINE BLOOD CHAMBER AND THE DIALYZER DURING HEMODIALYSIS THERAPY, AND OCCURRED DURING THE MIDPOINT OF THERAPY. THE CRIT-LINE BLOOD CHAMBER WAS TIGHTENED AS SOON AS THE LEAK WAS VISIBLE. THE PT WAS ABLE TO COMPLETE TREATMENT ON THE MACHINE. ESTIMATED PT BLOOD LOSS WAS MINIMAL (LESS THAN 5MLS). THE PT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE SAMPLE HAS BEEN DISCARDED. THE FACILITY WAS UNABLE TO PROVIDE PT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331979 CRIT-LINE BLOOD CHAMBER KOC FRESENIUS MEDICAL CARE NORTH AMERICA 1511310

    Patients

    Seq Age Sex Outcome Treatment
    1