BEUDAMED
    FDA Adverse Event Death Summary report: N

    KDJ SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3836153 · Received May 28, 2014

    Report

    Report Number
    1416980-2014-17201
    Event Type
    Death
    Date Received
    May 28, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13I06037, H13J03074 AND H13K01019 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF THE EVENT OF DEATH WAS NOT REPORTED. IT WAS REPORTED THAT A PATIENT ACQUIRED PERITONITIS AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH WAS REPORTED TO BE THE PATIENT'S BODY SHUTTING DOWN. ON AN UNREPORTED DATE, THE PATIENT'S BODY WAS SHUTTING DOWN AND EXPERIENCED STOMACH PAIN, VOMITING AND LOSS OF APPETITE FOR THREE WEEKS. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT DIED DUE TO THE EVENTS. IT WAS NOT REPORTED IF THE PERITONITIS HAD RESOLVED PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF THE PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE FOLLOWING DAY, THE PT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. TREATMENT WAS NOT REPORTED. SEVEN DAYS AFTER ADMISSION TO THE HOSPITAL, THE PT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PT WAS NOT RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312941 KDJ SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H HOMECHOICE| DIANEAL PD4 1.5% AND 2.5% AMBUFLEX| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| MINICAP