BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2961500 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03758
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A HEATER LINE THAT CAME DISCONNECTED FROM THE HEATER BAG ON THE HOME CHOICE (HC) DURING USE AND THE HOME PATIENT (HP) STATED SHE RECONNECTED THE HEATER LINE TO THE HEATER BAG AND CONTINUED THERAPY. THERE WERE NO ALARMS RECEIVED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CLOSE THE TRANSFER SET, PRESS STOP, RECYCLE POWER TO POWER RESTORED AND THEN END THERAPY. THE TSR ADVISED THE HP ANYTIME A LINE DISCONNECTS THAT SHE COULD NOT RECONNECT THE LINE AND CONTINUE THERAPY. THE TSR ADVISED THE HP THAT SHE WOULD NEED TO INFORM THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE LINE DISCONNECTING AND HER RECONNECTING THE LINE AND CONTINUING WITH THERAPY. THE HP WOULD DO A MANUAL EXCHANGE AND CONTACT THE PDRN. 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
    64854 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HOMECHOICE