BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2904386 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00660
    Event Type
    Death
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS INCIDENT. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12H29024 AND H12I18025. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE NURSE REPORTED THAT THE HOME PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. THE HOME PATIENT WAS NOT ON PERITONEAL DIALYSIS (PD) AT THE TIME OF DEATH. THE HOME PATIENT WAS SWITCHED TO HEMODIALYSIS IN JANUARY (DATE UNKNOWN) AND WAS OFF OF PD THERAPY FOR AT LEAST A MONTH PRIOR TO PASSING AWAY. THE HOME PATIENT WAS TREATED WITH (UNKNOWN) ANTIBIOTICS AND RECOVERED FROM THE PERITONITIS IN JANUARY. THE NURSE CONSIDERED THE PATIENT'S DEATH TO BE UNRELATED TO BAXTER SOLUTIONS, MACHINES, OR ANY DISPOSABLE PARTS. NO FURTHER INFORMATION WAS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ON UNREPORTED DATE, DIANEAL THERAPY WAS DISCONTINUED. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT AND THE CAUSE OF PERITONITIS WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10887 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H HOMECHOICE| DIANEAL PD4 AMBUFLEX