BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4062071 · Received September 4, 2014

    Report

    Report Number
    1416980-2014-29651
    Event Type
    Death
    Date Received
    September 4, 2014
    Date of Event
    July 15, 2014
    Report Date
    August 12, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY DUE TO AN UNKNOWN CAUSE COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE, IN THE SAME MONTH AS THE PATIENT¿S PASSING, THE PATIENT WAS HOSPITALIZED FOR AN UNREPORTED INDICATION. TREATMENT WAS NOT REPORTED. IT WAS NOT REPORTED IF PERITONEAL DIALYSIS (PD) THERAPY WAS ONGOING AT THE TIME OF DEATH. IT WAS REPORTED THAT THE PATIENT WAS PERFORMING AUTOMATED PERITONEAL DIALYSIS (APD) AT HOME AND ON AN UNREPORTED DATE WAS CHANGED TO EITHER CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) OR HEMODIALYSIS. IT WAS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE HOMECHOICE AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541673 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H DIANEAL PD4 2.5% AMBUFLEX