BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS

    MDR report key: 3851879 · Received April 17, 2014

    Report

    Report Number
    2937457-2014-00592
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS TO DATE INDICATED THE REPORTED MALFUNCTION OCCURRED DURING RECIRCULATION AND TREATMENT. THE USER DID NOT NOTICE THE SALINE BAG REFILLING WITH DIALYSATE DURING RECIRCULATION. 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 BUT THEY DID NOT NOTICE AND RAN A TREATMENT WITH THE PATIENT CONNECTED TO THE MACHINE DURING THE INCIDENT. PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. NO PARTS WERE REPLACED ON THE MACHINE. MANUFACTURER'S TECH INSPECTED AIR SEPARATOR ASSEMBLY AND NO PROBLEMS WERE FOUND. MACHINE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235823 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS KDI CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR UNK SALINE, DIALYZER