BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3041638 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08786
    Event Type
    Death
    Date Received
    April 8, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)94). THE CAUSE OF THIS PERITONITIS COULD NOT BE DETERMINED. 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. IF FURTHER RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WITH PERITONITIS, COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE HP WAS HOSPITALIZED FOR THE PERITONITIS AND WAS TREATED WITH UNKNOWN ANTIBIOTICS. THE FOLLOWING DAY THE HP PASSED AWAY, FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143638 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death| H| R DIANEAL AND EXTRANEAL