BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2992636 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05485
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DID NOT WEAR A MASK. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 EXPERIENCED PERITONITIS CAUSED BY THE PATIENT NOT WEARING A MASK, HAVING LOOSE MOTION, FURTHER DESCRIBED AS WATERY FECES, AND HAVING LESS ALBUMIN (1.7GM) DURING PERITONEAL DIALYSIS (PD) THERAPY USING UNKNOWN BAXTER PD DISPOSABLES. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH INJECTION (INJ) FORTUM, 1GM EVERY DAY (OD), AND INJ REFLIN, 1GM OD (ROUTES NOT REPORTED). THE OUTCOME OF THIS PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS RE-TRAINED ON ASEPTIC TECHNIQUES. PD THERAPY WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96952 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention DIANEAL PD2 1.5% ULTRABAG