BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1992032 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01987
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 24, 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY, INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNKNOWN DATE, THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE. IN 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS. IT WAS UNKNOWN IF DIANEAL THERAPY WAS ONGOING. THE PATIENT RECOVERED FROM THE BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS. THE REPORTER BELIEVED THAT THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS WAS DUE TO A BREAK IN ASEPTIC TECHNIQUE AND NOT RELATED TO THE DIANEAL THERAPY. NO CAUSALITY STATEMENT WAS GIVEN FOR THE BREAK IN ASEPTIC TECHNIQUE EVENT.

    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 PD4 ULTRABAG