BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2210978 · Received August 12, 2011

    Report

    Report Number
    6000001-2011-18853
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION, THAT HAD AN INOPERATIVE "OPEN" BUTTON ON CHANNEL B'S KEYPAD, WAS CONFIRMED BY SERVICE. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE AN INOPERATIVE KEYPAD DUE TO FLUID INTRUSION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER (B)(4) TO REPORT A COLLEAGUE INFUSION PUMP THAT HAD AN INOPERATIVE OPEN BUTTON ON CHANNEL B'S KEYPAD; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO REPORTED PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS 5.48.92. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1