BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1930734 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06962
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 25, 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. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IN (B)(6) 2007, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT RECEIVED ANY TREATMENT OR WHETHER DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE IN 2010, THE PATIENT RECOVERED FROM THE PERITONITIS WITH CULTURE POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE NURSE STATED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR PSEUDOMONAS AERUGINOSA WAS NOT RELATED TO DIANEAL PD2 ULTRABAG 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 51 YR Other DIANEAL PD2 ULTRABAG