BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3854819 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18300
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY FEVER, CLOUDY PERITONEAL EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE EVENT AND BEGAN TREATMENT WITH CEFAZOLIN, CEFTAZIDIME AND VANCOMYCIN (DOSES AND FREQUENCIES NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONITIS. ON AN UNKNOWN DATE, AFTER THE CULTURE RESULTS WERE REVEALED, THE PT SWITCHED ANTIBIOTIC THERAPY FROM IP TO INTRAVENOUS (IV) ROUTE AND BEGAN TREATMENT WITH FLUCONAZOLE (50 MG, EVERY 2 HOURS) IP FOR PERITONITIS. ANTIBIOTIC THERAPY WAS ONGOING. ON THE DAY FOLLOWING THE ONSET OF THE EVENT, PD THERAPY WAS DISCONTINUED AND THE PT BEGAN TREATMENT WITH HEMODIALYSIS. ON AN UNREPORTED DATE, THE PT REMAINED HOSPITALIZED AND WAS RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332948 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R PHYSIONEAL 40 1.36%