BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3934699 · Received July 15, 2014

    Report

    Report Number
    1416980-2014-22609
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTIONS (1GM, ONCE DAILY, INTRAVENOUSLY (IV), AND 1GM, INTRAPERITONEALLY(IP) ON THE 5TH DAY), MONOCEF INJECTIONS (1GM, ONCE DAILY, IP (DURATION NOT REPORTED), AND AMIKACIN INJECTION (500MG, ONCE DAILY, ROUTE AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. AFTER BEING HOSPITALIZED TWO DAYS FOR THE PERITONITIS EVENT, THE PATIENT WAS DISCHARGED. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERING OR HAD RECOVERED FROM THE PERITONITIS EVENT. IT WAS NOT REPORTED IF DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413729 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R DIANEAL 1.5% AND 2.5% PD2, DIANEAL 2.5% ULTRABAG