BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3983577 · Received August 6, 2014

    Report

    Report Number
    1416980-2014-25434
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    April 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS COMPLETED. A REVIEW OF THE EVENT LOGS WAS PERFORMED WITH NO ISSUES NOTED RELATED TO THE REPORTED PROBLEM. A VISUAL INSPECTION WAS PERFORMED AND REVEALED NO PHYSICAL DAMAGE TO THE DEVICE. ALL ELECTRICAL COMPONENTS WERE FOUND TO BE IN GOOD CONDITION. A FINAL TEST AND CALIBRATION WAS PERFORMED AND THE DEVICE PASSED ELECTRICAL, PRESSURE, THERMAL, AND VOLUMETRIC TESTING. A REVIEW OF THE DEVICE AND SERVICE HISTORY SHOWED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY. IN ADDITION, THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED BECAUSE THE DEVICE WAS DISTRIBUTED FOR USE OVER 5 YEARS AGO AND HAS BEEN RECONDITIONED/SERVICED SINCE ITS ORIGINAL MANUFACTURE DATE. THE DEVICE EVALUATION WAS COMPLETED. THE REPORTED EVENT OF A SMALL ELECTRICAL DISCHARGE COULD NOT BE VERIFIED THROUGH THE REVIEW OF THE LOGS OR VIA DEVICE EVALUATION. THE CAUSE COULD NOT BE DETERMINED. THE DEVICE MET PRODUCT SPECIFICATIONS RELATED TO THE REPORTED PROBLEM. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT EXPERIENCED A SMALL ELECTRICAL DISCHARGE FROM THE HOMECHOICE DEVICE WHEN IT WAS TURNED ON. THE PATIENT WAS LOADING THE CASSETTE AT THE TIME OF THE ELECTRICAL DISCHARGE. THE TECHNICAL SERVICE REPRESENTATIVE ARRANGED FOR 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
    461465 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1