BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 FOOT EXTENSION SET EASYLOCK CONNECTOR

    MDR report key: 1770648 · Received July 27, 2010

    Report

    Report Number
    1423500-2010-01652
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    THE WIFE OF A HOME PATIENT (HP) CONTACTED BAXTER AND REPORTED THAT THE HP HAD AN EVENT OF PERITONITIS. THE HP GOT PERITONITIS ON (B)(6) 2010 AND CONSEQUENTLY HAD THE TRANSFER SET REPLACED ON (B)(6) 2010. THE HP AT THE TIME WAS STILL ON ANTIBIOTICS. THE HP WENT IN TO THE CLINIC THE WEEK PRIOR AND HAD CLEAR EFFLUENT. THE HP HAS BEEN DOING FINE AND CONTINUING THERAPY ON THE CYCLER AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12 FOOT EXTENSION SET EASYLOCK CONNECTOR SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention