BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6158902 · Received December 9, 2016

    Report

    Report Number
    1416980-2016-18212
    Event Type
    Death
    Date Received
    December 9, 2016
    Report Date
    December 9, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY PASSED AWAY. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS AND WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC (DOSE, ROUTE AND FREQUENCY NOT REPORTED); HOWEVER, THE PATIENT¿S CONDITION WAS GETTING WORSE. PD THERAPY WAS DISCONTINUED. IT WAS REPORTED THAT THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS PRIOR TO TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE REPORTER DECLINED TO PROVIDE FURTHER INFORMATION ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811765 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R DIANEAL 1.5%| DIANEAL 2.5%