BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2213705 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-19263
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR THE DEVICE BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION: A DEVICE HISTORY REVIEW WAS PERFORMED FINDING A PUMP WITH AN ACCURACY READING FAILURE. PUMP WAS RETESTED 5 TIMES WITHOUT REPEATABLE FAILURE. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. DEVICE WAS NOT SENT IN FOR EVALUATION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS CONDITION WAS FOUND UPON POWER UP. THERE WAS NO REPORTED PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. THE SOFTWARE VERSION IS CURRENTLY UNKNOWN AT THIS TIME. 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