BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2010897 · Received March 8, 2011

    Report

    Report Number
    1423500-2011-02851
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE DEVICE'S DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT OVER TEMPERATURE FLUID DELIVERED ON A HOME CHOICE (HC) MACHINE DURING USE. THE HP STATED THE TEMPERATURE OF THE SOLUTION IN THE MANUAL BAG WAS 115 DEGREES FAHRENHEIT. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HC DEVICE WAS NOT SUPPOSED TO BE USED HEAT UP MANUAL BAGS. THE TSR EXPLAINED THAT WHEN USING THE HC, THE TEMPERATURE READINGS ARE TAKEN PRIOR TO FILL. THE TSR ASKED THE HP IF THE HC SHOWED TEMPERATURE STABILIZING. THE TSR INITIATED A SWAP OF THE MACHINE. THE HP CONFIRMED TO FINISH THERAPY VIA MANUAL SUPPLIES. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR