BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 5722786 · Received June 14, 2016

    Report

    Report Number
    1416980-2016-10672
    Event Type
    Death
    Date Received
    June 14, 2016
    Date of Event
    May 6, 2016
    Report Date
    July 26, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED TWO DAYS PRIOR TO PERITONITIS DIAGNOSIS FOR UNRELATED INDICATIONS. ON THE SAME DAY AS DIAGNOSIS, THE PATIENT WAS TREATED WITH VANCOMYCIN (2G, INTRAPERITONEALLY, FOR ONE DAY) AND GENTAMYCIN (8MG, INTRAPERITONEALLY, FOUR TIMES A DAY FOR ONE DAY) FOR THE PERITONITIS EVENT. THE PATIENT OUTCOME FOR THE PERITONITIS EVENT WAS NOT REPORTED. FIVE DAYS AFTER THE PERITONITIS DIAGNOSIS, THE PATIENT EXPERIENCED A CARDIAC ARREST AND PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS DUE TO A CARDIAC ARREST. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH BUT THE PATIENT WAS NOT PERFORMING THERAPY ON A HOMECHOICE DEVICE AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378552 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| R