BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3932937 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22545
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED AND THE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. DURING THE EVALUATION, THE PRODUCT WAS DETERMINED NOT TO MEET PRODUCT SPECIFICATION REQUIREMENTS. THE EVENT HISTORY LOG AND SAMPLE EVALUATION IDENTIFIED THE REPORTED PROBLEM TO BE A RELOAD THE SET 201 ALARM. IT WAS DETERMINED THAT THE CAUSE OF THE ALARM WAS A PROBLEM WITH THE DEVICE¿S O-RINGS. TO RESOLVE THE ISSUE, THE O-RINGS WERE REPLACED AND THE DEVICE WAS SENT FOR SERVICING. SUBSEQUENT FUNCTIONAL, ELECTRICAL AND CALIBRATION TESTING WERE PERFORMED WITH NO ADDITIONAL DEFECTS NOTED. A SIMULATED THERAPY WAS SUCCESSFULLY PERFORMED ON THE DEVICE. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED ISSUE OCCURRED DURING USE ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED THE RETURN OF THE DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410645 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1