BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2935994 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02330
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 9, 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). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. 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

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 2.5% AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL AND EXTRANEAL THERAPIES WAS UNKNOWN. ON (B)(4) 2013, A BAXTER CUSTOMER CARE REPRESENTATIVE WAS CONTACTED BY THE PATIENT AND THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD INTENSE PAIN AND WAS GIVEN PAIN KILLERS (UNSPECIFIED). ON AN UNREPORTED DATE, THE PATIENT WAS NAUSEATED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. IT WAS THOUGHT THAT THE PERITONITIS WAS DUE TO A WOOD BUG. ON AN UNREPORTED DATE WHILE USING THE PD CYCLER, THE PATIENT HAD TROUBLE SLEEPING ON HER SIDE. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE EVENTS OF INTENSE PAIN, NAUSEA AND TROUBLE SLEEPING ON SIDE. PER THE CONSUMER, THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENTS OF INTENSE PAIN, NAUSEATED AND TROUBLE SLEEPING ON SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40566 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization DIANEAL PD4 2.5%| EXTRANEAL