BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 3982868 · Received June 25, 2014

    Report

    Report Number
    2937457-2014-01596
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    K935958
    Removal / Correction Number
    Z-1715-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT THE CRIT LINE CHAMBER LEAKED BLOOD ON THE MACHINE. THE LEAK WAS VISUALLY OBSERVED INSIDE THE HANSEN. TEST STRIPS WERE NOT USED TO CONFIRM AND THE MACHINE DID NOT ALARM. ESTIMATED BLOOD LOSS WAS LESS THAN 100CC'S. PATIENT HAD NO ADVERSE EFFECT AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT COMPLETED TREATMENT. SAMPLE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370558 CRIT-LINE BLOOD CHAMBER KOC FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR