BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1891839 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05332
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT REQUESTED FOR THIS CASE OF PERITONITIS. THIS EVENT INVOLVES THREE BAXTER PRODUCTS. THIS MEDWATCH IS BEING SUBMITTED FOR THE SECOND OF THOSE THREE PRODUCTS.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WITH PERITONITIS AFTER FEELING PAIN DURING THE INITIAL DRAIN PHASE OF THERAPY. THE PATIENT HAD FULFILLED THE REQUIREMENTS OF THE INITIAL DRAIN AND THE TECHNICAL SERVICE REPRESENTATIVE HELPED TO ADVANCE THE PATIENT TO START CYCLE 1. THE CG NOTICED THAT THE FLUID IN THE PATIENT LINE TUBING WAS CLOUDY. FOLLOW UP CONVERSATION WITH THE NURSE REVEALED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PERITONITIS ON (B)(6) 2010 AND DISCHARGED ON (B)(6) 2010 AFTER THE INFECTION WAS RESOLVED. THE PATIENT STARTED HAVING ABDOMINAL PAIN AND WAS READMITTED TO THE HOSPITAL FOR PERITONITIS ON (B)(6) 2010 AND WAS SCHEDULED FOR DISCHARGE ON (B)(6) 2010. THE NURSE BELIEVED THAT THIS WAS A RECURRING PERITONITIS BECAUSE THE GRAM STAIN RESULTS ARE THE SAME AS THE FIRST EPISODE. FURTHER RESULTS OF THE RECURRING PERITONITIS WERE NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R