BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS

    MDR report key: 3922215 · Received May 23, 2014

    Report

    Report Number
    2937457-2014-00879
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS TO DATE INDICATED THE REPORTED MALFUNCTION OCCURRED DURING DIALYSIS MODE. THE USER VISUALLY OBSERVED THE SALINE BAG REFILLING WITH DIALYSIS DURING TREATMENT. 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 TREATMENT. A PT WAS CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO BLOOD LOSS. TREATMENT WAS COMPLETED WITH NO ISSUES AND THE PT DID NOT REQUIRE ANY MEDICAL INTERVENTION. THERE WERE NO ISSUES AND THE PT DID NOT REQUIRE ANY MEDICAL INTERVENTION. THERE WERE NO PARTS REPLACED ON THE DEVICE BY THE TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307125 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS KDI CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SALINE