BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1864253 · Received October 12, 2010

    Report

    Report Number
    1423500-2010-04323
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 18, 2010
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS REFERRED TO HER NURSE TO ADDRESS THE HOMECHOICE PROGRAMMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOME PATIENT CONTACTED BAXTER TO REPORT THE DISPLAY INDICATING FILL 1 OF 3 WHEN IT SHOULD BE FILL 1 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THAT THE HP WOULD NEED TO CONTACT THE NURSE FOR PROGRAMMING CHANGE. THE DEVICE WAS NOT SWAPPED. DURING A FOLLOW UP CALL, THE NURSE STATED THAT THE HP SOMEHOW CHANGED THE PROGRAMMING. THE ASSIGNABLE CAUSE FOR THE HOME PATIENT CHANGING THE PROGRAMMING WAS DETERMINED TO BE USE ERROR. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE RELATED TO THE REPORTED CONDITION. A LABELLING REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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 CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT PROGRAMMING ISSUES WITH THE HOMECHOICE (HC) DEVICE DURING FILL 1. THE HOMEPATIENT (HP) STATED THAT THE DISPLAY SAID FILL 1 OF 3 AND IT SHOULD BE FILL 1 OF 4 AND SHE WANTED HELP CHANGING IT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HP WOULD NEED TO CONTACT THE NURSE FOR PROGRAMMING CHANGE. FOLLOW UP WITH THE NURSE REVEALED THAT THE HP SOMEHOW CHANGED THE PROGRAMMING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1