BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3930929 · Received July 13, 2014

    Report

    Report Number
    1416980-2014-22481
    Event Type
    Death
    Date Received
    July 13, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13J04064 AND H14B03038 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, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (PREVIOUSLY REPORTED AS (B)(60 2014). DURING FOLLOW UP, FAILURE TO THRIVE WAS REPORTED AS AN ADDITIONAL CAUSE OF DEATH. 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 AND EVENTUALLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS IS UNKNOWN. THE PATIENT WAS HOSPITALIZED THE SAME DAY AS THE ONSET OF PERITONITIS. THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC (DOSE, ROUTE AND FREQUENCY NOT SPECIFIED) FOR THE PERITONITIS. FOUR DAYS AFTER HOSPITALIZATION, THE PATIENT WAS DISCHARGED AND WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS. THE PATIENT PASSED AWAY THREE WEEKS AFTER BEING DISCHARGED FROM THE HOSPITAL FOR THE PERITONITIS EVENT. THE CAUSE OF DEATH WAS REPORTED TO BE HEART FAILURE. PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409026 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| H| R DIANEAL PD2 ULTRABAG| HOMECHOICE PRO| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL PD2 AMBUFLEX