BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K HEMODIALYSIS SYS., WITH CDX

    MDR report key: 3802253 · Received March 24, 2014

    Report

    Report Number
    2937457-2014-00435
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K113427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE 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 TECH REPLACED THE AIR SEPARATOR AND THE MACHINE WAS PUT BACK INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171344 2008K HEMODIALYSIS SYS., WITH CDX KDI FRESENIUS MEDICAL CARE NORTH AMERICA T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SALINE