BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K HEMODIALYSIS SYS. OLC/DIASAFE PLS

    MDR report key: 3964349 · Received June 19, 2014

    Report

    Report Number
    2937457-2014-01109
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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

    A USER FACILITY REPORTED A SALINE BAG BACK FILLED DURING RECIRCULATION MODE. A PT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THE FACILITY TECHNICIAN REPLACED THE HIGH FLOW PRESSURE REGULATOR AND AIR SEPARATION CHAMBER ON THE DEVICE. THE PARTS WERE NOT RETURNED FOR EVAL AND THE MACHINE WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359242 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLS KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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