BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 4844426 · Received June 12, 2015

    Report

    Report Number
    2937457-2015-01175
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    K935958
    Removal / Correction Number
    Z-1716-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW 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. THE LEAK WAS VISUALLY OBSERVED EXITING OUT OF THE CRIT-LINE BLOOD CHAMBER. THE PT'S ESTIMATED BLOOD LOSS WAS NOT PROVIDED BY THE FACILITY. ADD'L ATTEMPTS HAVE BEEN MADE TO OBTAIN THE ESTIMATED BLOOD LOSS WITH NO ADD'L INFO PROVIDED. THE PT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PT COMPLETED TREATMENT. SAMPLE HAS BEEN DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384131 CRIT-LINE BLOOD CHAMBER KOC FRESENIUS MEDICAL CARE NORTH AMERICA 15011309

    Patients

    Seq Age Sex Outcome Treatment
    1