BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3042746 · Received April 9, 2013

    Report

    Report Number
    1416980-2013-08725
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 16, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING. THE PATIENT EXPERIENCED PERITONITIS DUE TO LOOSE MOTION. THE PATIENT WAS NOT HOSPITALIZED FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT'S TREATMENT STARTED WITH INJECTION AMIKACIN (125MG, ONCE DAILY [OD], ROUTE NOT REPORTED), INJECTION REFLIN (1.5G, OD, ROUTE NOT REPORTED), TABLET LINID (600MG, OD, ORALLY) AND VANCOMYCIN (1G, ONCE IN 5 DAYS, INTRAVENOUS [IV]) FOR PERITONITIS. THE OUTCOME OF THIS PERITONITIS EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146203 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention DIANEAL PD2 1.5%, DIANEAL PD2 2.5%