BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3170782 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15415
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 24, 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 PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) ANTIBIOTHERAPY WITH VANCOMYCIN 2 GRAM (ADMINISTRATION FREQUENCY ACCORDING TO SERUM CONCENTRATIONS) AND CEFTAZIDIME 1 GRAM/DAY, FOR 12 DAYS. TWO DAYS AFTER HOSPITALIZATION, REMEDIAL TREATMENT INCLUDED IMIPENEM (IP) 1 GRAM/DAY AND FLUCONAZOLE ORAL 100 MILLIGRAM/DAY WAS STARTED (16 DAYS OF TREATMENT). TWELVE DAYS AFTER HOSPITALIZATION, THE PATIENT WAS TREATED WITH VANCOMYCIN AND THE CEFTAZIDIME WAS WITHDRAWN. EIGHTEEN DAYS AFTER HOSPITALIZATION, IMIPENEM AND FLUCONAZOLE WERE WITHDRAWN. EIGHTEEN DAYS AFTER HOSPITAL ADMISSION, THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270679 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R DAGRAVIT, ETALPHA, MIMPARA,OMEPRAZOLE| CALCIUM CARBONATE, FOLICIL| PHYSIONEAL, EXTRANEAL, ARANESP, FUROSEMIDE, IRON