BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3140208 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13901
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED. THE CAUSE WAS UNKNOWN. THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN 2GRAM(G), INTRAPERITONEAL INJECTION (IP) EVERY 5 DAYS AND CEFTAZIDIME 1G/DAY IP. THREE DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. EIGHT DAYS AFTER HOSPITAL ADMISSION, THE VANCOMYCIN THERAPY WAS WITHDRAWN. FIFTEEN DAYS AFTER HOSPITAL ADMISSION, THE CEFTAZIDIME THERAPY WAS WITHDRAWN AND THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241983 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R TEGRETOL| PHYSIONEAL, EXTRANEAL, ZEMPLAR, ADALAT, MICARDIS| RASILEZ, CLONIDINE, CONCOR, RAMIPRIL, OMEPRAZOLE