BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2821260 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04180
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    July 1, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE 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 AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF POST-IMPLANTATION PERITONITIS AND SYSTEMIC EOSINOPHILIA IN A PATIENT COINCIDENT WITH PHYSIONEAL AND EXTRANEAL THERAPIES FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) DUE TO CHRONIC RENAL INSUFFICIENCY. ACTION TAKEN WITH PHYSIONEAL AND EXTRANEAL THERAPIES WERE NOT REPORTED. ON (B)(6) 2012, THE PATIENT'S EFFLUENT WAS CLOUDY. THE PHYSICIAN MADE THE DIAGNOSIS OF POST-IMPLANTATION PERITONITIS, BUT IN FURTHER COURSE THE PATIENT DEVELOPED A SYSTEMIC EOSINOPHILIA. TREATMENT WAS NOT REPORTED. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other EXTRANEAL| PHYSIONEAL 40 2.27%| ALLOPURINOL 100 1A PHARMA, CITALOPRAM ABZ, PRAVIDE| TORAGAMMA, XIPAMID AL, BISOPROLOL 1A PHARM| RENAGEL, ISOMOL, CALCIUM POLYSTYRENE SULFONATE| CARMEN, DOXAZOSIN 2 HEUMANN, PANTOPRAZOL NY| PHYSIONEAL 40 1.36%