BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1894418 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05534
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT INVOLVES FOUR BAXTER PRODUCTS. THIS MEDWATCH IS BEING SUBMITTED FOR THE FIRST OF THOSE FOUR PRODUCTS. AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOTS (H10G19011, H10F01128) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED THE TECHNICAL SERVICE REPRESENTATIVE AND STATED THAT THE FLUID HE IS DRAINING OUT IS VERY MILKY AND HE IS NOT FEELING GOOD DURING HIS INITIAL DRAIN PHASE OF THERAPY. THE HP DRAINED 221 MILLILITERS (ML) IN THE INITIAL DRAIN AND HIS LAST FILL VOLUME WAS 1000ML. THE TSR PERFORMED TROUBLE SHOOTING METHODS AND DID NOT UNCOVER ANY PROBLEMS SO HE ADVISED THE PATIENT TO CALL HIS PERITONEAL DIALYSIS NURSE. FOLLOW UP CONVERSATION WITH THE PATIENT'S NURSE REVEALED THAT THE PATIENT HAD PERITONITIS. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2010 AND BEGAN ANTIBIOTIC TREATMENT (UNKNOWN) AND IS DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R