BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3944677 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23273
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS BORN ON AN UNREPORTED DATE IN (B)(6). THE DEVICE WAS NOT RETURNED; 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

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED ON THE DAY OF ONSET FOR THE PERITONITIS. TREATMENT INFORMATION FOR THE PERITONITIS WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. DIANEAL THERAPIES WERE ONGOING UNTIL THE DAY OF DISCHARGE FROM THE HOSPITAL WHEN THEY WERE REPORTEDLY DISCONTINUED. TEN DAYS AFTER HOSPITALIZATION STARTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON THE DAY OF HOSPITAL DISCHARGE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE COAGULOPATHY AND PERITONITIS. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422674 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H DIANEAL 1.5% AND 2.5% PD4 ULTRABAGS