BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 3010222 · Received March 12, 2013

    Report

    Report Number
    2937457-2013-00016
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS ATTEMPTED TO OBTAIN MEDICAL RECORDS AND OTHER PERTINENT CLINICAL DATA FROM THE COMPLAINANT FACILITY VIA NUMEROUS REQUESTS. NO MEDICAL RECORDS HAVE BEEN OBTAINED TO DATE. A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) EVALUATION WAS PERFORMED ON THE MACHINE AND FOUND NO ISSUES OF FAILURES WITH OPERATION AND / OR MACHINE CALIBRATIONS. A CAUSE FOR PATIENT'S SYMPTOMS COULD NOT BE IDENTIFIED WITH THE INFORMATION PROVIDED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCE DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE PATIENT ARRIVED AT THE HEMODIALYSIS UNIT IN STABLE CONDITION. APPROXIMATELY 15 TO 30 MINUTES INTO THE HEMODIALYSIS TREATMENT, PATIENT WAS FOUND TO BE UNRESPONSIVE. ATTEMPTS TO RESUSCITATE THE PATIENT WITH BOTH BLS AND ACLS WERE UNSUCCESSFUL. THE PATIENT EXPIRED. THERE WERE NO REPORTED ISSUES WITH THE MACHINE BEFORE OR DURING THE TREATMENT. THE UNIT SUPERVISOR REPORTED THE HEMODIALYSIS MACHINE DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT AND THE FACILITY BIOMED TECHNICIAN REPORTED THE HEMODIALYSIS MACHINE CHECKED OUT OKAY DURING TESTING AFTER THE REPORTED ADVERSE EVENT ON (B)(6) 2012. NO MACHINE ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104582 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O DIALZYER| SALINE| BICARBONATE| ACID CONCENTRATE| BLOOD LINES