BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2172335 · Received July 22, 2011

    Report

    Report Number
    6000001-2011-13470
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BAD DISPLAY WAS CONFIRMED AND REPRODUCED. THE ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. UPON COMPLETION OF BAXTER?S INVESTIGATION A FOLLOW UP MED WATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A BAD DISPLAY, WHICH COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. THE REPORTED CONDITION OCCURRED DURING POWER UP IN THE BIOMED SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE SOFTWARE VERSION FOR THIS DEVICE IS CURRENTLY NOT KNOWN. 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