BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3182277 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16141
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A REVIEW OF THE SERVICE HISTORY FOR THE DEVICE REVEALED THERE IS NO PREVIOUS SERVICE HISTORY FOR THIS DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE EVENT HISTORY LOG OF THE DEVICE WAS REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED ISSUE. THE DEVICE PASSED BOTH ELECTRICAL AND FUNCTIONAL TESTING. EXTERNAL VISUAL INSPECTIONS FOUND NO ISSUES. THE POWER TO THE DEVICE WAS CYCLED MULTIPLE TIMES WITH NO ISSUES. THE DEVICE PASSED THE SEAL, PURGE, AND WET DISPOSABLE INTEGRITY TEST AND A SHORT SIMULATED THERAPY WAS PERFORMED ON THE DEVICE WITH NO ISSUES NOTED. AN INTERNAL INSPECTION FOUND NO BURNT ODOR, SMOKE OR SOOT. NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED ISSUE COULD NOT BE DUPLICATED OR CONFIRMED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURNT ODOR WAS COMING FROM A HOMECHOICE DEVICE (HC) WHEN THE HC WAS TURNED ON AND PATIENT NOT CONNECTED. THE HOME PATIENT (HP) STATED THAT THE HC SMELLED LIKE A SPOILED, BURNT EGG WITH A FOUL ODOR. THE HP WAS NOT SURE IF IT SMELLED LIKE A BURNING PART. THE HP STATED THERE WAS NO SMOKE, JUST A SMELL. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE DEVICE AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS UNTIL THE NEW MACHINE ARRIVED. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281895 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR