BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1964326 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00802
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 29, 2010
    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 TAIWAN OF BACTERIAL PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. IN (B)(6) 2009, THE PATIENT STARTED TREATMENT WITH DIANEAL PD4 ULTRABAG (LOT NUMBER, DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNKNOWN DATE IN 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS WITH A CULTURE POSITIVE FOR (B)(6) AND THE PATIENT WAS HOSPITALIZED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF DIANEAL THERAPY WAS ONGOING. THE EVENT OF THE PERITONITIS RESOLVED. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE REPORTER BELIEVED THAT THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS NOT RELATED TO THE DIANEAL THERAPY.

    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 Hospitalization DIANEAL PD4 ULTRABAG