BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2072285 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05174
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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). SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DIFFICULTY WAS NOT CONFIRMED AND A CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A THERAPY RESET ON THE HOMECHOICE (HC). THE CG STATED HE/SHE WENT TO SET UP FOR THERAPY AND NOTED THE THERAPY WAS RESET. THE CG STATED THAT HE/SHE GOT THE HC RE-PROGRAMMED. THE CG WAS NOT SURE OF ANY FURTHER DETAILS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED OF POSSIBLE CAUSES. THE CG CONFIRMED TO CALL BACK IF THIS SITUATION REOCCURS. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1