BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2980900 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04787
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER WAS UNKNOWN; THEREFORE A SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS CONFIRMED TO BE CAUSED BY USE ERROR AS THERE WAS A BREAK IN ASEPTIC TECHNIQUE BY THE USER, DESCRIBED AS MADE MISTAKE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD CONSTIPATION AND A BREAK IN ASEPTIC TECHNIQUE, FURTHER DESCRIBED AS MADE A MISTAKE, THAT CAUSED PERITONITIS WHILE USING UNKNOWN PD DISPOSABLES DURING PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS TREATED WITH AN INJECTION (INJ) FORTUM (1 GM/5 DAYS), INTRAPERITONEALLY (IP), AND INJ REFLIN (1 GM/DAY), IP, FOR THE PERITONITIS. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. THE PATIENT WAS RE-TRAINED ON PROPER ASEPTIC TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84839 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DIANEAL PD2 1.5% AND 2.5% ULTRABAG