BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3200066 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16911
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE SERVICE HISTORY REVEALED NO FAILURES OR PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE DEVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE REPORTED ISSUE WAS CONFIRMED UPON REVIEW OF THE DEVICE LOG. THE DEVICE PASSED ELECTRICAL AND FUNCTIONAL TESTS. INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED WITH NO ISSUE FOUND. A CHECK OF THE PNEUMATIC SYSTEM FOUND THE SYSTEM TO BE WORKING TO SPECIFICATIONS. MULTIPLE SHORT SIMULATED THERAPIES WERE PERFORMED AND PASSED SUCCESSFULLY. THE CAUSE WAS DETERMINED TO BE INSUFFICIENT DRAIN, ONE OR MORE CYCLES WERE ADVANCED TO THE NEXT FILL WHEN A SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. NO FAILURE OR MALFUNCTION WAS IDENTIFIED WITH THE DEVICE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS FOR THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) FELT OVERFILLED AND WANTED TO REPLACE THE HOMECHOICE (HC) MACHINE. THE HP FELT VERY FULL IN DWELL TWO BUT CONTINUED WITH THERAPY. THE HP STATED THAT THEY HAD AN ULTRAFILTRATION (UF) OF 700 ML AT THE END OF THERAPY AND HAD A MANUAL DRAIN OF OVER 600 ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP TURN ON THE MACHINE AND LOOK THROUGH THE DEVICE HISTORY. THE ULTRAFILTRATION (UF) FOR CYCLE THREE WAS 1978 ML, -312 ML FOR CYCLE TWO, -357 ML FOR CYCLE ONE, AND A TOTAL UF OF 1309 ML. THE TSR 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
    299569 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR