BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3914352 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21555
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN 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 HOMECHOICE (HC) DEVICE WAS EVALUATED. A VISUAL INSPECTION WAS PERFORMED ON THE DEVICE. THE HC UNDERWENT FUNCTIONAL AND ELECTRICAL TESTING ALONG WITH SIMULATED THERAPY. THE DOOR WAS FOUND TO HAVE WORKED FINE AND THERE WERE NO ADDITIONAL DEFECTS AND MALFUNCTIONS IDENTIFIED WITH THE DEVICE. THE EVENT HISTORY LOG REVIEW WAS COMPLETED AND THERE WAS A SYSTEM ERROR (SE) 2084 (ILLEGAL DOOR OPEN) IDENTIFIED TO HAVE OCCURRED ON (B)(6) 2014. ALTHOUGH THE REPORTED ALARM WAS UNKNOWN, IT WAS REPORTED AS AN ALARM ON THE ¿DOOR¿ AND WAS THEREFORE VERIFIED AS A SE 2084 IN THE LOG. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED ALARM ("ALARMS ON DOOR") 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
    389695 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1