BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE 1.7

    MDR report key: 2152303 · Received July 7, 2011

    Report

    Report Number
    6000001-2011-10695
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: DEVICE WAS NOT RECEIVED BY BAXTER AND WAS REPAIRED ON-SITE. THE DEVICE WAS REPAIRED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN. THIS CONDITION WAS CONFIRMED THROUGH A REVIEW OF THE EVENT HISTORY. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS NOT IDENTIFIED AS THE CONDITION WAS NOT RELATED TO THE CUSTOMER REPORTED CONDITION. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED 19 OCCURRENCES OF AN AIR DETECTED SET ALARM. THIS CONDITION MAY HAVE BEEN A FALSE ALARM. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE 1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1