BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2122310 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07537
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET 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). THE HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). THE ISSUE OF RETURN INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL TEST FAILED IN FILL 1, DRAIN 1, FILL 2, AND DRAIN 2 & LAST FILL WAS CONFIRMED BY REVIEW OF THE RITE FUNCTIONAL TEST REPORT. NO PROBLEMS WERE REVEALED DURING INSPECTION AND ALL CONNECTIONS WERE CORRECT AND SECURE. THE CAUSE OF THE RITE FAILURE WAS DETERMINED TO BE A COMBINATION OF TORN LD FOAM AND CRACKED DOOR PISTON. A SERVICE HISTORY REVIEW (SHR) REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE DEVICE WAS SENT TO SERVICING FOR CORRECTION AND THE DOOR PISTON FOAMS AND DOOR PISTON WERE SCRAPPED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1