BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4250231 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40254
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR ANALYSIS AND AN EVALUATION HAS BEGUN BUT HAS NOT YET BEEN COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. THE EVENT HISTORY LOG REVIEW DID NOT VERIFY THE REPORTED EVENT. SAMPLE EVALUATION FOUND NO NONCONFORMING PRODUCT AND THE DEVICE PASSED EXTERNAL/INTERNAL VISUAL INSPECTION. A SHORT SIMULATED THERAPY WAS SUCCESSFULLY PERFORMED. RETURNED HOMECHOICE DEVICES RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. REVIEW OF SERVICE HISTORY DATA REVEALED PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED EVENT WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT FELT OVERFULL DURING PERITONEAL DIALYSIS THERAPY ON THE HOME CHOICE. IT IS UNKNOWN IN WHAT CYCLE THE INCIDENT OCCURRED. THE PATIENT¿S LARGEST PRESCRIBED FILL VOLUME WAS 2000ML AND THEIR DRAIN VOLUME EQUALED 3600ML. IT IS UNKNOWN HOW THE PATIENT COMPLETED THERAPY. NO FURTHER THERAPY INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737480 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR