BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2212431 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10736
    Event Type
    Death
    Date Received
    August 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO EVALUATION OR BATCH REVIEW WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS (H10K14023 AND H10J23026) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    GLOBAL PHARMACOVIGILANCE (GPV) RECEIVED A REPORT OF A MALE PATIENT DEATH FROM A CONSUMER COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL UNKNOWN THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES THE FOLLOWING INFORMATION WAS PROVIDED: ON UNREPORTED DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED PERITONITIS. IN (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR CARDIAC SURGERY. FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED COMPLICATIONS INCLUDING BEING UNABLE TO WEAN THE PATIENT FROM THE VENTILATOR. ON (B)(6) 2011, THE PATIENT EXPIRED. THE NURSE REPORTED THE CAUSES OF DEATH WERE DUE TO CARDIAC DISEASE, PERIPHERAL VASCULAR DISEASE (PVD), AND BEING FRAIL. THE CONSUMER STATED THE CAUSE OF DEATH WAS RELATED TO THE PERITONITIS. THE NURSE STATED THAT SHE DID NOT AGREE WITH THE CONSUMER'S REPORTED CAUSE OF DEATH BUT DID CONFIRM THE EVENT OF PERITONITIS. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS UNKNOWN IF DIANEAL THERAPY WAS ONGOING AT THE TIME OF DEATH. THE NURSE STATED THE EVENT OF DEATH WAS NOT RELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death DIANEAL PD4 AMBUFLEX| DIANEAL UNKNOWN| HOMECHOICE