BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1903748 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06040
    Event Type
    Death
    Date Received
    November 20, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10F19047, H10G20092, H10H30073), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE HAD MIGRATED. REVISION SURGERY TO REPOSITION THE DEVICE OCCURRED ON (B)(6), 2010. THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS, FATAL CARDIAC FAILURE, FATAL MYOCARDIAL INFARCTION, AND FATAL SEPSIS IN A (B)(6) MALE COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT DEVELOPED PERITONITIS. IT WAS UNREPORTED IF THE PATIENT WAS HOSPITALIZED OR IF TREATMENT WAS PROVIDED FOR THE PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT DIED OF CARDIAC FAILURE, A MYOCARDIAL INFARCTION, AND SEPSIS. IT WAS UNREPORTED IF TREATMENT WAS RENDERED PRIOR TO THE FATAL EVENTS. IT WAS UNREPORTED IF AN AUTOPSY WAS PERFORMED. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN AND THE PATIENT WAS PLACED ON HEMODIALYSIS. IT WAS UNREPORTED IF THE PATIENT RECOVERED FROM THE PERITONITIS. PER THE NURSE, THE PERITONITIS, FATAL CARDIAC FAILURE, FATAL MYOCARDIAL INFARCTION, AND FATAL SEPSIS WERE UNRELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| R DIANEAL PD4 AMBUFLEX