BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 4840449 · Received June 11, 2015

    Report

    Report Number
    2937457-2015-01164
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 13, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    K935958
    Removal / Correction Number
    FA-2015-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS, THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. CUSTOMER TIGHTENED THE LOOSE CRIT-LINE BLOOD CHAMBER AND CONFIRMED THAT THE LEAK WAS RESOLVED. NO PART WAS RETURNED, AN EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    A CLINIC REPORTED A BLOOD LEAK FROM A CRIT-LINE BLOOD CHAMBER. THE LEAK WAS VISUALLY OBSERVED COMING FROM THE CRIT-LINE BLOOD CHAMBER. THERE WERE NO REPORTED ADVERSE EFFECTS ON THE PATIENT NOR MEDICAL INTERVENTION. BLOOD LOSS WAS REPORTED AS A MINIMAL AMOUNT LEAKING FROM AROUND THE CHAMBER. THE DEVICE HAS BEEN DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382085 CRIT-LINE BLOOD CHAMBER KOC FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1