BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2082499 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05675
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF CHECK TOTAL VOLUME ALARM WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE THE THERAPY PARAMETERS BEING RESET. NO ISSUES WERE IDENTIFIED DURING REVIEW OF THE DEVICE HISTORY RECORD AND THE SERVICE HISTORY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE THERAPY BEING RESET. THE ASSIGNABLE CAUSE FOR THERAPY BEING RESET WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) STATING THAT THE HOMECHOICE (HC) SHOWS CHECK TOTAL VOLUME. THE TOTAL VOLUME WAS 200ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THERAPY WAS RESET. THE TSR ADVISED THE HOME PATIENT (HP) TO CONTACT THE NURSE (RN) TO RE PROGRAM THE HC. DURING FOLLOW UP, THE PERITONEAL DIALYSIS (PD) RN STATED THAT THE PROGRAM HAD BEEN CORRECTED AND THE PD RN SAW THE HP ON (B)(6) 2011 FOR CLINICS AND STATED THE HP DIDN'T MENTION ANYTHING AND LOOKED GREAT. THE PD RN STATED THE HP WAS DOING FINE ON THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 82 YR