BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3243428 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19494
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE PASSED BOTH ELECTRICAL AND FUNCTIONAL TESTING. THE HEATER PAN TEMPERATURES WERE MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATION. THE REPORTED ISSUE COULD NOT BE CONFIRMED OR DUPLICATED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SOLUTION WAS TOO HOT AS IT WAS FILLING THE HOME PATIENT (HP) WHILE THEY WERE PERFORMING THE PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC) DEVICE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO USE THE MANUAL SUPPLIES IN ORDER TO PERFORM THE THERAPY. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344074 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR PD DISPOSABLES