BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2110904 · Received June 2, 2011

    Report

    Report Number
    6000001-2011-06968
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED BY SERVICE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS DETERMINED TO BE A FAULTY AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) ON CHANNEL C. TO CORRECT THE CONDITION, THE AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) ON CHANNEL C WAS REPLACED AND CALIBRATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A COLLEAGUE INFUSION PUMP EXPERIENCED AN AIR-IN-LINE ALARM, AND THIS WAS FOUND TO BE A FALSE ALARM. THIS OCCURRED DURING SERVICE EVALUATION BY BAXTER PERSONNEL. THERE WAS NO KNOWN PATIENT INVOLVED; THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SOFTWARE VERSION IS NOT AVAILABLE AT THIS TIME.

    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