BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1850569 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-03993
    Event Type
    Death
    Date Received
    October 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOTS, H10G09012, WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE WAS DISCARDED, THEREFORE NO EVALUATION WAS PERFORMED.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A US NURSE OF INFECTION IN A FINGER AND FATAL FUNGAL PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE REPORTED ON AN UNSPECIFIED DATE IN 2010 THE PATIENT DEVELOPED AN INFECTION IN A FINGER (UNKNOWN) WHICH REQUIRED AMPUTATION. ON AN UNSPECIFIED DATE IN 2010, THE PATIENT EXPERIENCED FUNGAL PERITONITIS. IT IS UNKNOWN WHAT TREATMENT AND INTERVENTIONS WERE PROVIDED FOR THE FUNGAL PERITONITIS. ON (B)(6) 2010, THE PATIENT EXPIRED. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS REPORTED AS FUNGAL PERITONITIS. DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE PATIENT'S DEATH. PER THE NURSE, THE EVENTS OF INFECTION IN THE FINGER AND FATAL FUNGAL PERITONITIS WERE UNRELATED TO DIANEAL THERAPY. THIS IS THE 1ST OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death DIANEAL PD4 AMBUFLEX