BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4200642 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37332
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. SAMPLE ANALYSIS REVEALED NO PRODUCT ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. 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 EVENT WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, OR SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FEELS LIKE THE MACHINE IS SHOCKING HER. IF THE HOME PATIENT TOUCHES SOMETHING WHILE ON THE MACHINE SHE GETS A STRANGE SENSATION LIKE ITCHINESS OR BURNING. THIS OCCURRED DURING USE; THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679290 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1