BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXTENSION SET

    MDR report key: 2941900 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02799
    Event Type
    Death
    Date Received
    February 4, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12J08041 AND H12J30037 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER IN THE USA OF FATAL PERITONITIS INFECTION IN A MALE PATIENT (BORN IN (B)(6)) COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX THERAPY (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). THE DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT DIED. THE CAUSE OF THE DEATH WAS PERITONITIS INFECTION (ONSET DATE NOT REPORTED). THE TREATMENT FOR THE EVENT OF PERITONITIS INFECTION WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. THE NURSE WAS CONTACTED BUT DECLINED TO PROVIDE FURTHER INFORMATION. BAXTER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47303 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death DIANEAL PD2 AMBUFLEX