BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073409 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05237
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A CHECK YOUR POSITION ALARM. THE PATIENT STATED THAT THERE WAS AIR IN THE PATIENT LINE. USED SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE, COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. 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

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A CHECK YOUR POSITION ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING FILL 1. THE HP STATED THERE WAS AIR IN THE PATIENT LINE. TROUBLESHOOTING STEPS COULD NOT CLEAR THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THEY WOULD NEED TO START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS DONE VIA PHONE. THE HOME PATIENT STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES, NO FURTHER ISSUES WERE FOUND. THE HOME PATIENT ALSO STATED THAT THEY HAVE ALREADY DISPOSED OF THE SUPPLIES AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOME CHOICE