BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3041474 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08748
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. 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 UNSPECIFIED PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AND EXTRANEAL THERAPIES FOR END STAGE RENAL DISEASE (ESRD). PD THERAPY WAS ONGOING. THE PATIENT WAS ALREADY HOSPITALIZED FOR AN UNSPECIFIED INDICATION WHEN THE PATIENT WAS REPORTED TO HAVE BEEN USING EXTRANEAL AND EXPERIENCED UNSPECIFIED PERITONITIS. REMEDIAL TREATMENT CONSISTED OF UNSPECIFIED ANTIBIOTICS. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. THIS IS ONE OF SEVERAL REPORTS FROM THE SAME REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142718 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R DIANEAL PD4 1.36% AND EXTRANEAL