BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1840526 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03606
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 30, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT DISCARDS SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS THE "PATIENT MADE A MISTAKE, DID NOT WEAR A MASK, AND AREA NOT CLEAN BEFORE STARTING PERITONEAL DIALYSIS". ON (B)(6)2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM (1GM, THREE TIMES A DAY). PD THERAPY WAS ONGOING. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention DIANEAL PD2 ULTRABAG