BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3082700 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10663
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    February 11, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) IN BELGIUM EXPERIENCED ENCAPSULATING PERITONEAL SCLEROSIS (EPS). ON AN UNREPORTED DATE, APPROXIMATELY 4 YEARS AND 7 MONTHS PRIOR TO THIS REPORT, THE PT BEGAN TREATMENT WITH PHYSIONEAL 35, (6.4 LITERS (L), DAILY) AND ONE YEAR LATER THE PT BEGAN TREATMENT WITH EXTRANEAL (1.3 L, DAILY), (LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). EXTRANEAL AND PHYSIONEAL THERAPIES WERE ONGOING. ON UNREPORTED DATE PRIOR TO DIAGNOSIS OF EPS, THE PT EXPERIENCED A BELLY ACHE AND DIGESTIVE SYMPTOMS. THE PATIENT WAS DIAGNOSED WITH EPS. THE EVENT OF EPS OCCURRED DURING PD TREATMENT. THERE WAS NO USE OF DISINFECTANTS OR ANTISEPTICS. THE PATIENT HAD A NORMAL NUTRITIONAL STATUS. IT WAS NOT KNOWN WHETHER ASCITES WAS PRESENT. THERE WAS NO CIRRHOSIS. TWENTY DAYS AFTER DIAGNOSIS, THE PATIENT BEGAN REMEDIAL THERAPY WITH MEDROL (METHYLPREDNISOLONE), (32 MG, ONCE DAILY) ONGOING AT TIME OF THIS REPORT. A GRAFT FROM LIVING DONOR WAS SCHEDULED WITHIN ONE MONTH (DATES UNSPECIFIED). THE OUTCOME OF THE EPS WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185867 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention VASEXTEN (BARNIDIPINE HYDROCHLORIDE)| RAMIPRIL| D-CURE (CHOLECALCIFEROL)| ROCALTROL (CALCITRIOL)| CALCIUM CARBONATE (CACO3))| ARANESP (DARBEPOETIN ALFA)| PHYSIONEAL 35, 1.36% (13.6 MG/ML)| EXTRANEAL| FUROSEMIDE