BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPD DISCONNECT Y SET

    MDR report key: 4093762 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31586
    Event Type
    Death
    Date Received
    September 16, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14E08048 AND H14D01095 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. 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 PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH WAS REPORTED TO BE SEPTIC SHOCK AND PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS NOT REPORTED. TREATMENT FOR THE PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT 3 DAYS PRIOR TO PASSING AWAY. IT WAS NOT REPORTED IF DIANEAL THERAPIES WERE ONGOING PRIOR TO OR AT THE TIME OF DEATH. IT WAS NOT REPORTED IF THERAPY WITH A BAXTER DEVICE AND/OR BAXTER PD SOLUTIONS WAS BEING PERFORMED UP TO OR AT THE TIME OF DEATH. IT WAS NOT REPORTED IF THE PATIENT HAD RECOVERED OR WAS RECOVERING FROM THE PERITONITIS EVENT PRIOR TO PASSING AWAY. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573646 CAPD DISCONNECT Y SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| H CASSETTE, MINICAP, HOMECHOICE,| DIANEAL PD4, 2.5% AMBUFLEX,| DIANEAL PD4, 4.25% AMBUFLEX