BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3203590 · Received July 3, 2013

    Report

    Report Number
    1416980-2013-17074
    Event Type
    Death
    Date Received
    July 3, 2013
    Date of Event
    May 25, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS, WHICH MANIFESTED AS CLOUDY EFFLUENT. THE PATIENT WAS TREATED WITH VANCOMYCIN IP (1.5 GRAMS ONE TIME ONLY) AND GENTAMICIN IP (ONCE DAILY FOR THREE DAYS, DOSE UNKNOWN) FOR THE PERITONITIS. THE DAY AFTER THE PATIENT COMPLETED ANTIBIOTIC THERAPY, THE PATIENT EXPERIENCED RESPIRATORY ARREST. ON THE SAME DAY, THE PATIENT DIED. THE DEATH WAS DUE TO CONGESTIVE HEART FAILURE, RESPIRATORY ARREST, PERITONITIS AND FLUID OVERLOAD. PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306548 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R DIANEAL PD4 AMBUFLEX THERAPIES 2.5% AND 4.25%| HOMECHOICE