BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS

    MDR report key: 3596419 · Received January 22, 2014

    Report

    Report Number
    2937457-2014-00103
    Event Type
    Injury
    Date Received
    January 22, 2014
    Date of Event
    December 26, 2013
    Report Date
    December 26, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS FINDINGS TO DATE INDICATED THE REPORTED MALFUNCTION OCCURRED DURING RECIRCULATION AND PRIME (MACHIN SET-UP), AND NOT DURING DIALYSIS MODE. THE USER VISUALLY OBSERVED THE SALINE GAB REFILLING WITH DIALYSATE DURING CIRCULATION. THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSUE. THE REPORT IS BEING INVESTIGATED BY THE MFR 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 THE USER FACILITY THAT THE SALINE BAG WAS BACK FILLING DURING RECIRCULATION. A PATIENT WAS NOT CONNECTED TO THE MACHIN AT THE TIME OF INCIDENT THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. TECHNICIAN REPLACED THE AIR SEPARATOR CAP AND 'O' RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53449 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SALINE