BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3173779 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15624
    Event Type
    Death
    Date Received
    June 17, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS, WAS ADMITTED TO THE HOSPITAL AND SUBSEQUENTLY EXPIRED. GENTAMYCIN 5 MG PER L INTRAPERITONEALLY (IP) AND VANCOMYCIN 1.5 MG PER L IP (FREQUENCIES NOT REPORTED) WERE ADDED TO THE PERITONEAL DIALYSIS (PD) SOLUTIONS AS REMEDIAL TREATMENT. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED NO BLOOD PRESSURE. THE PATIENT WAS ADMITTED TO AN INTENSIVE CARE UNIT AND THE PD THERAPY WAS DISCONTINUED. ON THAT SAME DATE, THE PATIENT DIED. THE ROOT CAUSE OF THE PERITONITIS WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274092 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| R EXTRANEAL| DIANEAL