BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HEMODIALYSIS SYS., WITH CDX

    MDR report key: 3833054 · Received March 25, 2014

    Report

    Report Number
    2937457-2014-00450
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 24, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K113427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS TO DATE INDICATE 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 THIS REPORTED ISSUE. THIS REPORT IS BEING INVESTIGATED BY THE MANUFACTURER VIA A CAPA. THE INVESTIGATION IS PENDING; A SUPPLEMENT MDR WILL BE FILED AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED SALINE BAG BACK FILLED DURING THE FIRST SETUP OF THE DAY AFTER RECIRCULATION HAD BEEN RUNNING FOR AN UNKNOWN AMOUNT OF TIME. THE SYSTEM ALARMED FOR FILLING PROGRAMS. THE SYSTEM WAS REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT. ON SITE TECHNICIAN CHECKED THE SYSTEM BUT WAS UNABLE TO REPRODUCE THE PROBLEM. NO PARTS WERE REPLACED. THE SYSTEM WAS PLACED BACK INTO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173772 2008T HEMODIALYSIS SYS., WITH CDX KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SALINE (DISCARDED - NOT USED)