BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2211178 · Received August 15, 2011

    Report

    Report Number
    1423500-2011-10695
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF BURNING SMELL WAS CONFIRMED DURING VISUAL INSPECTION. THE DEVICE WAS RECEIVED INOPERATIVE FOR NO POWER. THE MAIN INPUT FUSES WERE REPLACED BUT THE DEVICE REMAINED INOPERATIVE. THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST FOR BEING RECEIVED INOPERATIVE AND POWER UP VERIFICATION BUT PASSED THE RITE ELECTRICAL TEST. THE PAL EVALUATED THE DEVICE. DURING AN INTERNAL INSPECTION A BURNING SMELL WAS DETECTED COMING FROM THE POWER SUPPLY. FURTHER INSPECTION REVEALED DAMAGE TO THE POWER SUPPLY AS A RESULT OF FLUID INGRESS. THE POWER SUPPLY WAS REPLACED WITH THE TEST ARTICLE AND THE DEVICE POWERED UP WITH NO PROBLEMS. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE OF BURNING SMELL WAS DETERMINED TO BE AN INOPERATIVE POWER SUPPLY AS A RESULT OF FLUID INGRESS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEMS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A BURNT ODOR ON A HOMECHOICE (HC) MACHINE DURING SET UP. THE HP STATED SHE COULD SMELL BURNING WIRES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE MACHINE. THE HP WAS ADVISED TO CONTACT THE REGISTERED NURSE (RN) FOR PROGRAMMING. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS A PATIENT INVOLVED, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1