BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1971632 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01103
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REQUESTING ASSISTANCE WITH THE HOME CHOICE (HC) MACHINE DURING DWELL. THE CG STATED THE HC WAS BLOWING OUT BREAKERS IN HIS HOUSE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE CG IF HE WAS SURE THE HC WAS DOING IT; THE CG STATED THAT HE SHUT OFF EVERYTHING IN THE HOUSE, AND IT STILL DID IT. THE CG STATED IT WAS ALSO VERY NOISY. THE TSR WILL HAVE THE HC SWAPPED. THE CG STATED THE HOME PATIENT (HP) WILL HAVE THE NURSE PROGRAM THE NEW HC AND THE HP WILL FINISH WITH MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE CASSETTE