BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2122308 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07536
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER CONTACTED THE PATIENT REGARDING THE REPORTED PROBLEM OF PROGRAM CHANGED BY DEVICE. THE WIFE OF THE PATIENT STATED THAT HE WAS OK AND WAS ABLE TO CONTINUE THERAPY. THE WIFE STATED THE TECHNICAL SERVICE REPRESENTATIVES HELPED THEM UNDERSTAND THE ALARM. SHE STATED THAT A REGISTERED NURSE COMES EVERYDAY TO HELP WITH THERAPY AND PROGRAMMING. NO SAMPLE WAS AVAILABLE. THIS COMPLAINT FOR PROGRAM CHANGED BY DEVICE WAS CONFIRMED. THE CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER (B)(4) REGARDING A THERAPY ISSUE. THE HP STATED THAT HE IS IN DWELL 1 OF 6 WHEN HE SHOULD BE IN DWELL 1 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CALL THE NURSE TO REVIEW THE PROGRAMMING AS SOON AS POSSIBLE. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1