BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YUME SET FOR UV FLASH

    MDR report key: 1725736 · Received June 16, 2010

    Report

    Report Number
    1423500-2010-01160
    Event Type
    Injury
    Date Received
    June 16, 2010
    Date of Event
    March 30, 2010
    Report Date
    June 1, 2010
    Manufacturer
    BAXTER HEALTHCARE SINGAPORE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE SAMPLE WAS NOT RETURNED THEREFORE NO EVALUATION WAS PERFORMED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE ROOT CAUSE COULD NOT BE IDENTIFIED UPON COMPLETION OF BAXTER'S INVESTIGATION. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B) (6) OF PERITONEAL CLOUDY EFFLUENT IN A MALE PATIENT COINCIDENT WITH DIANEAL-N PD-4 1.5% THERAPY AND USING AN APD CASSETTE. ON (B) (6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO PERITONEAL CLOUDY EFFLUENT. DURING THE HOSPITALIZATION THE PATIENT DEVELOPED EOSINOPHILIC PERITONITIS. STEROIDS (UNKNOWN) WERE ADMINISTERED FOR THE EVENT. A BLOOD COUNT REVEALED THE EOSINOPHIL COUNT WAS INCREASED. PERITONEAL EFFLUENT ANALYSIS REVEALED 1740/MM3 OF WHITE BLOOD CELL AND NEGATIVE FOR GRAM STAIN. ALTHOUGH DIAGNOSIS OF PERITONITIS BACTERIAL WAS MADE AND ANTIBIOTIC WAS ADMINISTERED, WHICH SHOWED UNRESPONSIVE. TESTS FOR FUNGUS AND TUBERCULOUS ORGANISM REVEALED NEGATIVE. AS PERITONEAL EFFLUENT REVEALED 80% (1200/MM3) OF EOSINOPHILS, DIAGNOSIS OF EOSINOPHILIC PERITONITIS WAS MADE. THE PHYSICIAN INITIALLY SUSPECTED ALLERGIC REACTION TO DEVICE. ON (B) (6) 2010, THE PATIENT BEGAN DIANEAL-N PD-4 1.5% THERAPY. ON (B) (6) 2010, DIANEAL-N PD-4 1.5% THERAPY WAS WITHDRAWN AND THE PATIENT WAS CHANGED TO PERITONEAL DIALYSIS (PD) THERAPY WITH MIDPELIQ. THE PHYSICIAN STATED THAT THE EVENT WAS PROBABLY RELATED TO DIANEAL-N PD-4 1.5% THERAPY. IN (B) (6) 2010, THE EVENT WAS RESOLVING AND THE PATIENT WAS DISCHARGED FROM HOSPITAL. AT THE TIME OF THIS REPORT, PD THERAPY WAS CONTINUED UNCHANGED. THE PHYSICIAN BELIEVED THE EVENT WAS POSSIBLY RELATED TO DIANEAL-N PD-4 1.5% THERAPY AND THE APD CASSETTE, BECAUSE SIMILAR CASES CAUSED BY SOLUTION OR APD SET WERE REPORTED IN LITERATURE. THE PHYSICIAN CONSIDERED THE EVENT HAD PROLONGED THE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YUME SET FOR UV FLASH SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE SINGAPORE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R DIANEAL-N PD-4 1.5% THERAPY