BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4123597 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33529
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, THE PATIENT'S PD CATHETER WAS REMOVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. 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 REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THERAPY BEING PERFORMED WITHOUT PROPER TRAINING. FOLLOWING THE ONSET OF PERITONITIS THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE THE PATIENT BEGAN TREATMENT WITH INJECTION REFLIN (1G INTRAPERITONEALLY (IP), ONCE DAILY, AND DURATION NOT REPORTED) AND FORTUM (1G, IP, ONCE DAILY, AND DURATION NOT REPORTED) FOR THE EVENT OF PERITONITIS. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THE PERITONITIS. DIANEAL 1.5% ULTRABAG THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602301 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R DIANEAL 1.5% ULTRABAG AND DIANEAL 2.5% ULTRABAG.