BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3203531 · Received July 3, 2013

    Report

    Report Number
    1416980-2013-17076
    Event Type
    Death
    Date Received
    July 3, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 6, 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 FOR PERITONITIS HAVE BEEN RECEIVED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE EVENT ON THE SAME DAY. THE NEXT DAY, THE PD CATHETER WAS REMOVED, PD THERAPY WAS WITHDRAWN AND THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS. THE TREATMENT FOR THE PERITONITIS INCLUDED VANCOMYCIN AND GENTAMICIN (DOSAGE, FREQUENCY, AND ROUTE NOT REPORTED). WHILE HOSPITALIZED, THE PATIENT EXPERIENCED A FATAL AND UNSPECIFIED CARDIAC EVENT. THE PATIENT WAS STILL RECOVERING FROM PERITONITIS AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306168 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| H| R HOMECHOICE| DIANEAL PD4 1.36% AND 4 2.27%| EXTRANEAL