BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2972324 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04335
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. 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. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPIES FOR PERITONEAL DIALYSIS (PD). THE PATIENT HAD NOTICED A LEAKING DRAIN BAG. THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND SLIGHT TENDERNESS IN THEIR ABDOMEN AND GROIN REGIONS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT INITIALLY HOSPITALIZED FOR THE EVENT BUT WAS LATER HOSPITALIZED FOR LOADING ANTIBIOTICS IN THEIR PD SOLUTION. THE PATIENT WAS TREATED WITH TOBRAMYCIN AND CEFAZOLINE FOR THE PERITONITIS. PD THERAPIES WERE ONGOING. THE PATIENT RECOVERED FROM THIS EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77185 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R DIANEAL PD4 1.5% AND 2.5%, EXTRANEAL