BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4252762 · Received November 15, 2014

    Report

    Report Number
    1416980-2014-40810
    Event Type
    Injury
    Date Received
    November 15, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 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 USE ERROR THAT RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT MADE A MISTAKE DURING THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION (2 GRAMS ONCE IN 5 DAYS; ROUTE NOT REPORTED) AND FORTUM INJECTION (2 GRAMS ONCE DAILY; ROUTE NOT REPORTED) FOR THE EVENT. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT HAD BEEN RETRAINED ON ASEPTIC TECHNIQUE. OUTCOME OF THE EVENT WAS NOT REPORTED. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. EXTRANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740470 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention DIANEAL 2.5% AND 4.25% ULTRABAG, AND EXTRANEAL