BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3200984 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-16992
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE LOG DID NOT FIND ANYTHING RELATED TO THE REPORTED ISSUE. THE DEVICE PASSED ELECTRICAL AND FUNCTIONAL TESTS. EXTERNAL AND INTERNAL VISUAL INSPECTIONS WERE PERFORMED AND FOUND NO ISSUES WITH THE DEVICE. THE PNEUMATIC SYSTEM WAS TESTED AND FOUND NO LEAKS. ALL PRESSURES WERE CORRECT AND STABLE. A SIMULATED THERAPY WAS RUN ON THE DEVICE SUCCESSFULLY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE DEVICE WITH THIS SERIAL NUMBER. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WERE RELATED TO THE REPORTED CONDITION. DURING EVALUATION, THE DEVICE PASSED THE SEAL, PURGE AND WET DISPOSABLE INTEGRITY TESTING. DURING EVALUATION, NO FAILURES AND MALFUNCTIONS WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. AS A RESULT, THE CAUSE CANNOT BE DETERMINED. THE DEVICE WAS GOING TO BE SENT TO SERVICE AREA FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) FELT OVERFILLED WITH PERFORMING THERAPY ON A HOMECHOICE (HC) MACHINE DURING DWELL. THE CAREGIVER (CG) STATED THAT THE HP PERFORMED A MANUAL DRAIN AFTER THEY FELT OVERFILLED. THE DRAIN VOLUME WAS NOT REPORTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED TO SWAP THE DEVICE AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS UNTIL THE NEW MACHINE ARRIVED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303115 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE