BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2091714 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06078
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 23, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE WAS DUE TO USE ERROR, POOR ASEPTIC TECHNIQUE. THE DEVICE INVOLVED IN THE INCIDENT WAS 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A BAXTER HEALTHCARE PROFESSIONAL FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT DEVELOPED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL TREATMENT WITH REFLIN (1 GRAM, IP, LOADING DOSE). THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. THE EVENT OF PERITONITIS WAS RESOLVING. DIANEAL THERAPY WAS ONGOING. THE REPORTER STATED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention DIANEAL PD2 ULTRABAG