BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HEMODIALYSIS SYS., WITH CDX

    MDR report key: 3639387 · Received December 30, 2013

    Report

    Report Number
    2937457-2013-00593
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    November 23, 2013
    Report Date
    December 2, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K093902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS TO DATE INDICATE THE REPORTED MALFUNCTION OCCURRED IN IDLE MODE DURING DIALYSIS MODE. THE USER VISUALLY OBSERVED THE SALE BAG REFILLING WITH DIALYSATE DURING CIRCULATION. THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH THIS REPORTED ISSUE. THIS REPORT IS BEING INVESTIGATED BY THE MANUFACTURER VIA A CAPA. THE INVESTIGATION IS PENDING, A SUPPLEMENTAL MDR WILL BE FILED AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN REPORTED A SALINE BAG BACK FILLED 15-20 MINUTES INTO RECIRCULATION. THERE WAS NO PT INVOLVEMENT. THE FLOW PRESSURE RELEASE VALVE WAS REPLACED. THE MACHINE DID NOT HAVE FURTHER ISSUES AFTER THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680669 2008T HEMODIALYSIS SYS., WITH CDX KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SALINE