BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 4844238 · Received June 3, 2015

    Report

    Report Number
    2937457-2015-01029
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    March 20, 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
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    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. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS NECESSARY. TREATMENT WAS SUCCESSFULLY COMPLETED. ESTIMATED BLOOD LOSS WAS REPORTED AS APPROXIMATELY 10 ML. THE DEVICE HAS BEEN DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359298 CRIT-LINE BLOOD CHAMBER KOC FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1