BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1972061 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01132
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 3, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    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 RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF CULTURE POSITIVE FUNGAL PERITONITIS IN A PATIENT (AGE AND GENDER NOT REPORTED) COINCIDENT WITH DIANEAL PD2 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. IN (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX (10L) AND EXTRANEAL VIAFLEX (2L) (FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) AND AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED FUNGAL PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE IN 2010, THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS. DIANEAL PD2 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES WERE WITHDRAWN. IT WAS NOT REPORTED WHETHER THE FUNGAL PERITONITIS RESOLVED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THAT DIANEAL PD2 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES WERE NOT RELATED TO THE FUNGAL PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL PD2 AMBUFLEX AND EXTRANEAL VIAFLEX