BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3850337 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-17961
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 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). THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY RESULTING IN THE DEVELOPMENT OF PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT MADE A MISTAKE. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH INJECTION VANCOMYCIN (1.5MG, ROUTE AND FREQUENCY NOT REPORTED) AND INJECTION AMIKACIN (250MG, ROUTE AND FREQUENCY NOT REPORTED). IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330048 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R DIANEAL 1.5% PD2 AMBUFLEX