BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOME CHOICE PRO

    MDR report key: 3150738 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14546
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED. NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE OF SCROTAL SWELLING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. THE DEVICE PASSED RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TEST, HOWEVER FAILED THE RITE FUNCTIONAL TEST ?POWER UP VERIFICATION? SECTION DUE TO AN ALARM. THIS DEVICE WAS NOT DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. HOWEVER, THIS FAILED TEST DID NOT CONTRIBUTE TO THE REPORTED CONDITION OF AN ENLARGED SCROTUM. AN EXTERNAL AND INTERNAL INSPECTION WERE PERFORMED, WITH NO OTHER PROBLEMS ENCOUNTERED. THE PROBLEM WAS NOT CONFIRMED AND THEREFORE A CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CAREGIVER (CG) REPORTED THE PATIENT EXPERIENCED ENLARGED SCROTUM. THE CAREGIVER REPORTED THIS EVENT WAS RELATED TO A FLUID LEAK AND WAS UNABLE TO REPORT THE CAUSE. THE PATIENT WAS SCHEDULED FOR A FOLLOW UP APPOINTMENT WITH HIS PHYSICIAN TO DISCUSS CHANGING SOLUTION STRENGTH DUE TO THE REPORT OF EXPERIENCING ENLARGED SCROTUM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250975 HOME CHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other DIANEAL