BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2023460 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03362
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF BURNING ODOR WAS CONFIRMED DURING VISUAL INSPECTION. THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST FOR BEING RECEIVED INOPERATIVE, AND ALSO FOR POWER UP VERIFICATION. THE DEVICE PASSED THE RITE ELECTRICAL TEST. A BURNT ODOR WAS PRESENT DURING AN INTERNAL INSPECTION, WHICH REVEALED THE J1 ACCOMP BOARD / POWER HARNESS CONNECTOR EXHIBITING SIGNS OF OVERHEATING. ACCOMP BOARD AND POWER HARNESS WERE REPLACED. THE ASSIGNABLE CAUSE FOR BURNING ODOR WAS DETERMINED TO BE AN OVERHEATED J1 CONNECTOR ON THE ACCOMP BOARD. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A POWER FAILURE ON A HOMECHOICE (HC) MACHINE DURING PRIME, PATIENT NOT CONNECTED. THE HOME PATIENT (HP) STATED THAT DURING THE PRIME PHASE THE MACHINE TURNED OFF AND HP NOTICED A BURNED ODOR. THE HP WAS USING A POWER CORD EXTENSION. THE HP STATED THAT HE UNPLUGGED THE MACHINE FROM THE EXTENSION AND TRIED USING THE WALL OUTLET BUT THE MACHINE WOULD NOT COME BACK ON. THE TSR INITIATED A SWAP OF THE DEVICE. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS 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 45 YR