BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE1 PUMP UNREFURB

    MDR report key: 2033032 · Received March 29, 2011

    Report

    Report Number
    6000001-2011-02331
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    October 2, 2009
    Report Date
    March 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 WAS CONFIRMED DURING DEVICE EVALUATION. THE ROOT CAUSE WAS DETERMINED TO BE AN AIL (AIR IN LINE) PCB (PRINTED CIRCUIT BOARD) FAILURE. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. A SERVICE HISTORY REVIEW REVEALED THIS DEVICE WAS NOT PREVIOUSLY SERVICED BY BAXTER. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTIONS, NONCONFORMANCES, OR REWORK OCCURRED DURING THE MANUFACTURING OF THE DEVICE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA (B)(4). SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    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.

    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 FAILURE CODE 810:11, WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF 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 CXE1 PUMP UNREFURB PUMP, INFUSION FRN BAXTER HEALTHCARE - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1