BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 4834538 · Received June 9, 2015

    Report

    Report Number
    2937457-2015-01124
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 13, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    K935958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TIGHTENED THE LOOSE CRIT-LINE BLOOD CHAMBER AND CONFIRMED THAT THE LEAK WAS RESOLVED. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL, AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE; THEREFORE AN EVAL COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED TO BE AN EXTERNAL LEAK LOCATED AT THE THREADED BOTTOM END OF THE CRIT-LINE BLOOD CHAMBER THAT ATTACHES TO THE DIALYZER. THE MACHINE DID NOT ALARM. ESTIMATED BLOOD LOSS WAS MINIMAL. THE PT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PT COMPLETED TREATMENT. SAMPLE IS NOT AVAILABLE FOR MFG EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372188 CRIT-LINE BLOOD CHAMBER KOC FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1