BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3260185 · Received August 1, 2013

    Report

    Report Number
    1416980-2013-20392
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THE DAY OF THE ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED FOR FOURTEEN DAYS WITH AN INJECTION OF VANCOMYCIN (1 MG, ONCE (IN EACH BAG), AND INTRAPERITONEAL (IP)), AN INJECTION OF CEFAZOLIN (1 MG IN EACH BAG, IP, FREQUENCY NOT REPORTED), AND AN INJECTION OF CEFTAZIDIME (1 MG IN EACH BAG OF DIANEAL 1.5%, IP, FREQUENCY NOT REPORTED). AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL IN THE HOSPITAL. THE PATIENT OUTCOME WAS UNKNOWN. THE PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359868 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DIANEAL PD-2 ULTRABAG 1.5%