BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3131674 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13586
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BAXTER HEALTHCARE
    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). 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 FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INJECTION (INJ). FORTUM (250MILLIGRAM (MG), INTRAPERITONEAL INJECTION (IP), AND FREQUENCY NOT REPORTED) AND INJ. AMIKACIN (50MG, IP, AND FREQUENCY NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237384 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R DIANEAL PD2 ULTRABAG 2.5%