BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2770481 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01448
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 15, 2012
    Report Date
    September 15, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). SUSPECT MEDICAL DEVICE INFO AND A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME. THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING A CHECK SUPPLY LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DISPLAY, DURING USE, WHILE THE PATIENT WAS CONNECTED, IN FILL, THE HOME PATIENT (HP) STATED THEY DISCONNECTED HEATER BAG AND LAST FILL BAG THEN SWITCHED THEM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HP THEY HAD COMPROMISED THE SETUP AND ASSISTED THEM WITH ENDING THE THERAPY. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 BAG