BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3132106 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13516
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 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; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CAUSE OF THIS PERITONITIS WAS USE ERROR DESCRIBED AS BREAK IN ASEPTIC TECHNIQUE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS CHANGE OF ROOM AND THE AREA WAS NOT CLEANED BEFORE STARTING PERITONEAL DIALYSIS (PD) THERAPY WITH UNKNOWN BAXTER DISPOSABLES. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH AN INJECTION (INJ.) OF NEOMYCIN 50MG (ALTERNATIVE BAG), INTRAPERITONEALLY (IP) (FREQUENCY WAS NOT REPORTED) AND AN INJ. OF TARGOCID 400MG (ALTERNATIVE BAG), IP (FREQUENCY WAS NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED. OUTCOME OF PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236667 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DIANEAL PD2 ULTRABAG 2.5%