BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2114113 · Received June 6, 2011

    Report

    Report Number
    1423500-2011-07066
    Event Type
    Death
    Date Received
    June 6, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER (B)(4) RECEIVED A CALL FROM A HOME PATIENT'S (HP) NURSE WHO STATED THAT A FAMILY MEMBER REPORTED THAT THE HP PASSED AWAY WHILE HOSPITALIZED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ON (B)(6) 2011, A PHYSICIAN REPORTED THAT THE EVENT OF DEATH WAS AMENDED TO CARDIAC FAILURE. ON (B)(6) 2011, THE HP BEGAN DIANEAL-N PD-4 1.5 UV TWIN BAG THERAPY INTRAPERITONEALLY (IP). ON (B)(6) 2011, THE HP DIED. IT WAS NOT REPORTED WHETHER THE HP WAS HOSPITALIZED OR TREATED FOR THE EVENT PRIOR TO HIS DEMISE, OR WHETHER AN AUTOPSY WAS PERFORMED. PERITONEAL DIALYSIS (PD) THERAPY WAS ONGOING UNTIL DEATH. THE PHYSICIAN STATED THAT THE FATAL EVENT WAS UNRELATED TO PD THERAPY DUE TO HIS MEDICAL HISTORY OF HEART DISEASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H DIANEAL LOCAL(PD4)TWINBAG