BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2073297 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05233
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A DEVICE HISTORY REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    WHILE ASSISTING THE HOME PATIENT (HP) WITH RE-PRIMING THE PATIENT LINE ON THE HOMECHOICE (HC) SYSTEM DURING THE INITIAL DRAIN, AS REQUESTED, THE HP REVEALED THAT HE HAD ALREADY PRESSED GO ON THE HC TO START THE INITIAL DRAIN, BUT WAS NOT YET CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THE THERAPY AND TO START OVER WITH ALL NEW SUPPLIES. 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 HC CASSETTE