BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3898761 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20450
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW UP IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE PATIENT WAS HOSPITALIZED APPROXIMATELY 1 MONTH PRIOR TO PASSING AWAY FOR AN UNRELATED INDICATION AND WAS HOSPITALIZED AT THE TIME OF DEATH. DIANEAL THERAPY HAD BEEN DISCONTINUED PRIOR TO THE PATIENT PASSING AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE END STAGE RENAL DISEASE, CORONARY ARTERY DISEASE (CAD), PNEUMONIA, C-DIFF, SEPSIS, AND A CORONARY BYPASS GRAFT. IT WAS UNKNOWN IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT PRIOR TO PASSING AWAY. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. TREATMENT FOR THE EVENTS RELATED TO THE PATIENT PASSING AWAY WAS NOT REPORTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FEW DAYS AROUND THIS EVENT, THE PATIENT EXPERIENCED CLOUDY WHITE EFFLUENT WHICH WAS CONSIDERED A MANIFESTATION OF PERITONITIS. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13K14046 AND H14B28035 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 RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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 BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THAT PRIOR TO THE ONSET OF THE PERITONITIS, THE PATIENT HAD BEEN HOSPITALIZED FOR AN UNRELATED INDICATION. ELEVEN DAYS AFTER HOSPITALIZATION, THE PATIENT ACQUIRED PERITONITIS. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ¿MEDICINES AND ANTIFUNGALS¿ (NAME, DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS. IT WAS REPORTED THAT DURING HOSPITALIZATION, THE PD CATHETER WAS REMOVED, PD THERAPY WAS DISCONTINUED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED AND WAS NOT RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377827 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| R HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL 1.5% AND 2.5% SINGLEBAG| HOMECHOICE| MINI-CAP