BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXTENSION SET

    MDR report key: 3142356 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14060
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS OBTAINED BY THE HOME PATIENT'S NURSE REPORTING THE HOME PATIENT'S DEATH. THE NURSE CONFIRMED THE PATIENT HAD PERITONITIS. THE CAUSE OF THE PERITONITIS WAS DUE TO A SPLEEN INFARCTION AND DIVERTICULITIS. THE NURSE STATED THE PERITONITIS EVENT DID NOT RESOLVE PRIOR TO THE PATIENT'S DEATH. THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO DISCONTINUING PERITONEAL DIALYSIS. THE NURSE STATED THE PATIENT'S FAMILY DECIDED TO DISCONTINUE PERITONEAL DIALYSIS THERAPY (PD). PER THE NURSE, THE PATIENT'S LAST PD TREATMENT WAS ON (B)(6) 3013. THE PATIENT WAS NOT CONNECTED TO THE HOME CHOICE DEVICE AT THE TIME OF DEATH AND DID NOT EXPERIENCE AN OVERFILL EVENT. THE CAUSE OF THE SPLEEN INFARCTION AND DIVERTICULITIS WERE UNKNOWN. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13A21066 AND H13B13061 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). PD THERAPY WAS ONGOING. THE CAUSE OF THE PERITONITIS WAS DIVERTICULITIS AND SPLEEN INFARCTION. THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. THE PATIENT WAS TREATED WITH VANCOMYCIN AND GENTAMYCIN IP (DOSE AND FREQUENCY NOT REPORTED). THE PATIENT WAS STILL HOSPITALIZED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. THIS IS REPORT 3 OF 4 FOR THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243343 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H| R HOMECHOICE, DIANEAL AMBUFLEX| MINICAP, MINICAP TRANSFER SET| HOMECHOICE AUTOMATED PD SET WITH CASSETTE