BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4928008 · Received July 21, 2015

    Report

    Report Number
    1416980-2015-29549
    Event Type
    Death
    Date Received
    July 21, 2015
    Date of Event
    May 15, 2015
    Report Date
    July 2, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT, FEVER, AND BEING ¿PRETTY SICK¿. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. BEGINNING ON THE DAY OF ONSET, THE PATIENT WAS TREATED WITH VANCOMYCIN (ROUTE, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) AND AN UNKNOWN SECOND ANTIBIOTIC (ROUTE, MEDICATION, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. THE CAUSE OF DEATH WAS REPORTED AS PERITONITIS AND THREE ADDITIONAL NON-RELATED EVENTS. ON THE DAY OF ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT AND THE PATIENT WAS HOSPITALIZED AT THE TIME OF DEATH. THE PATIENT WAS NOT RECOVERED FROM THE PERITONITIS EVENT PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ONE DAY PRIOR TO DEATH, DIANEAL AND EXTRANEAL THERAPIES WERE STOPPED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472158 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| R HOMECHOICE, DIANEAL 2.5% AND 4.25% PD4| EXTRANEAL 7.5%