BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K 2 HEMODIALYSIS MACHINE

    MDR report key: 3851878 · Received April 17, 2014

    Report

    Report Number
    2937457-2014-00594
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS TO DATE INDICATED THE REPORTED MALFUNCTION OCCURRED DURING DIALYSIS PAUSED MODE. THE USER VISUALLY OBSERVED THE SALINE BAG REFILLING WITH DIALYSATE DURING DIALYSIS PAUSED MODE; SALINE BAG NOTICED TO BE OVERFILLING IMMEDIATELY AFTER PATIENT TAKEN OFF TREATMENT. 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 DIALYSIS PAUSED MODE. SALINE BAG NOTICED TO BE OVERFILLING IMMEDIATELY AFTER PATIENT WAS TAKEN OFF TREATMENT. FACILITY STATED THAT A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THERE WERE NO PARTS REPLACED ON THE DEVICE BY THE TECHNICIAN. MACHINE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235512 2008K 2 HEMODIALYSIS MACHINE KDI CONCORD MANUFACTURING

    Patients

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