BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K2 HEMODIALYSIS SYS OLC/DIASAFE PLS

    MDR report key: 3952586 · Received May 15, 2014

    Report

    Report Number
    2937457-2014-00813
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS FINDINGS TO DATE INDICATED THAT 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

    A USER FACILITY REPORTED A SALINE BAG BACK FILLED DURING RECIRCULATION MODE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THE MANUFACTURER REPLACED THE AIR SEPARATOR ASSEMBLY AND THE MACHINE WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290839 2008K2 HEMODIALYSIS SYS OLC/DIASAFE PLS KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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