BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4233755 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39200
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER REPORTED "[HAVING] CHECK HEATER LINE ALARMS 2-3 TIMES IN THE PAST YEAR. PER THE PATIENT THE REASON THE ALARMS OCCURRED WAS THAT THEY HAD PINCHED THE SOLUTION PORTS WHEN LIFTING THE SOLUTION BAGS UP OUT OF THE BOXES. THE PINCHED PORTS WOULD RESTRICT FLUID FLOW RESULTING IN THE ALARMS. THEY HAVE SINCE CHANGED THE WAY THEY PICK UP THE SOLUTION BAGS AND HAVE NOT HAD PROBLEMS SINCE. THE PATIENT ALSO REPORTED THAT WHEN THE FLUID FLOW WAS RESTRICTED DUE TO THE PINCHED PORTS THE FLUID IN THE HEATER BAG WOULD GET HOT." THE CUSTOMER ALSO STATED THAT "BY REPOSITIONING THE HEATER BAGS THEY WERE ABLE TO RESOLVE THE PROBLEMS". A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DIRECT CAUSE OF THE PROBLEM WAS THAT THE BAGS WERE NOT POSITIONED PROPERLY ON THE HEATER PAN. A REVIEW OF THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, IN THE SECTION ¿PREPARE YOUR SOLUTION BAGS¿ STATES IN THE WARNINGS ¿THE SOLUTION BAG MUST BE POSITIONED PROPERLY ON THE HEATER PAN. BE SURE THAT THE BAG COMPLETELY COVERS THE SILVER HEATER SENSOR BUTTON. ADDITIONAL CARE SHOULD BE TAKEN WHEN POSITIONING SMALL SOLUTION BAGS ON THE HEATER. IF THE SOLUTION BAG IS NOT PLACED PROPERLY, OVERHEATED OR UNDERHEATED DIALYSIS FLUID CAN BE DELIVERED.¿ SHOULD ADDITIONAL RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOME CHOICE (HC) MACHINE, IT WAS REPORTED THE HOMECHOICE HAD OVERHEATED SOLUTION DURING PERITONEAL DIALYSIS THERAPY. IT IS UNKNOWN WHAT STEP OF THERAPY THIS OCCURRED. THE HOME PATIENT (HP) WAS CONNECTED. FOLLOW-UP DETERMINED THE PATIENT COMPLETED THERAPY USING THE SAME SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REPORT ONE OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715684 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1