BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4103200 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32421
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF SERVICE HISTORY DATA REVEALED PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. REVIEW OF THE EVENT HISTORY LOG VERIFIED THE EVENT. SIMULATED THERAPY WAS PERFORMED AND FINISHED WITH NO ISSUES NOTED. A CHECK OF THE PNEUMATIC SYSTEM FOUND THE PNEUMATIC SYSTEM WORKING TO SPECIFICATIONS. RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE EVENT WAS UNEXPECTED HIGH UF AS THE PATIENT WAS DISCONNECTED, BUT DID NOT ABORT THERAPY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A HIGH DRAIN 105 ALARM. A HIGH DRAIN ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THIS ALARM OCCURRED AT START-UP OF THE HOMECHOICE (HC) MACHINE FOR A PERITONEAL DIALYSIS (PD) THERAPY SESSION. FOR THE PREVIOUS THERAPY SESSION, THE PATIENT STATED THAT THEY HAD DISCONNECTED EARLY WITHOUT TURNING OFF THE HC MACHINE, AND WATER DRAINED OUT OF THE PATIENT LINE AFTER THIS DISCONNECTION. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE PATIENT TO COMPLETE THERAPY USING MANUAL EXCHANGE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581557 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR