BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3840767 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17403
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 7, 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). (B)(6). THE DEVICE WAS RECEIVED BUT THE EVALUATION HAS YET TO BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A REVIEW OF THE EVENT LOG WAS PERFORMED WITH AN UNRELATED ISSUE NOTED. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONAL TESTING, ELECTRICAL TESTING, CALIBRATION, AND A SIMULATED THERAPY WERE PERFORMED. IT WAS NOTED DURING TESTING THAT THE DEVICE MADE NOISE. THE REPORTED PROBLEM WAS IDENTIFIED AS NOISY ¿ PD HARDWARE AND THE CAUSE WAS DETERMINED TO BE PUMP ADHESIVE FOAM PADS. THE FOAM PADS WERE SCRAPPED AND THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED EVENT 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
    319468 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1