BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2962419 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03837
    Event Type
    Death
    Date Received
    February 14, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF ONSET UNKNOWN. THIS COMPLAINT FOR PERITONITIS-NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER, THERE WAS NO LOT NUMBER GIVEN AND NO ISSUES AND NO DEVIATIONS FROM STANDARD PROCEDURE WERE REPORTED. THE COMPLAINT INVESTIGATION DID NOT DESCRIBE ANY TYPES OF USE ERRORS THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. THEREFORE, THE COMPLAINT IS NOT CONFIRMED AND THE ASSIGNABLE CAUSE IS DETERMINED AS NO DEVICE MALFUNCTION OR USE ERROR IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD PERITONITIS WAS HOSPITALIZED AND SUBSEQUENTLY PASSED AWAY. IT WAS REPORTED PD THERAPY WAS DISCONTINUED, BUT THE ACTUAL DATE IS UNKNOWN. THE PATIENT HAD SYMPTOMS OF DIFFICULTY BREATHING, NO URINE OUTPUT AND WORSENING SITE INFECTION. THE HP WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU) FOR 7 DAYS WHERE HE WAS SEDATED AND INTUBATED. THE HP DIED DUE TO UNKNOWN CAUSE. IT WAS UNKNOWN AT THE TIME OF THE REPORT IF AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64699 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death DIANEAL 1.5%, EXTRANEAL AND HOME CHOICE