BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3203170 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17091
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 9, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. 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. 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. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED FOR AN UNREPORTED INDICATION. ON AN UNREPORTED DATE, THE PATIENT HAD BREAK IN ASEPTIC TECHNIQUE WHICH CAUSED PERITONITIS. TWO DAYS LATER, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY HAZY DIALYSATE. ON AN UNREPORTED DATE, THE PATIENT STARTED TREATMENT WITH VANCOMYCIN (1GM, FREQUENCY, AND ROUTE NOT REPORTED) AND GENTAMYCIN (12.5 (UNITS NOT REPORTED), FREQUENCY, AND ROUTE NOT REPORTED) FOR PERITONITIS. THE NEXT DAY THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302870 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R DIANEAL PD2 1.5%| DIANEAL PD2 4.25%