BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3241390 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19350
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPY WAS DISCONTINUED AND THE PATIENT BEGAN HEMODIALYSIS. THE BREAK IN ASEPTIC TECHNIQUE WAS REPORTED TO BE THAT THE PATIENT DID NOT WEAR A MASK WHEN SETTING UP THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH IP VANCOMYCIN 1 GRAM (FREQUENCY NOT REPORTED). AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341504 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R DIANEAL 1.5%, 2.5% AND HOMECHOICE