BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HEMODIALYSIS SYS WITH CDX

    MDR report key: 4102180 · Received September 17, 2014

    Report

    Report Number
    2937457-2014-02724
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K093902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 DIALYSATE DURING TREATMENT. THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSU. 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. NURSE STATED THAT THE PT WAS SENT TO THE HOSP FOR AN EVAL AND WAS NOT ADMITTED. PT HAD NO ADVERSE EFFECTS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE TECH REPLACED HIGH FLOW RELIEF VALVE 78 AND CHECKED THE AIR SEPARATOR PROBES FOR PRECAUTION. MACHINE IS BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575988 2008T HEMODIALYSIS SYS WITH CDX KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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