BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HEMODIALYSIS SYS., WITH CDX

    MDR report key: 3791889 · Received January 22, 2014

    Report

    Report Number
    2937457-2014-00095
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    December 23, 2013
    Report Date
    December 23, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS FINDINGS TO DATE INDICATED THE REPORTED MALFUNCTION OCCURRED DURING RECIRCULATION AND PRIME (MACHINE SET-UP), AND NOT DURING DIALYSIS MODE. THE USER VISUALLY OBSERVED THE SALINE BAG REFILLING WITH DIALYSATE DURING CIRCULATION. THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSUE. THE 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

    IT WAS REPORTED BY A USER FACILITY THAT A SALINE BAG BACK FILLED DURING RECIRCULATION. HE STATED THAT THERE WAS NO PATIENT INVOLVEMENT. HE SERVICED THE MACHINE RIGHT AWAY. HE REPLACED THE AIR SEPARATOR, VALVE 43, AND FLOW RELEASE VALVE. THE MACHINE DID NOT HAVE ANY ISSUES EVER SINCE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53641 2008T HEMODIALYSIS SYS., WITH CDX KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SALINE