BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2223406 · Received August 25, 2011

    Report

    Report Number
    6000001-2011-20649
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 814:01 WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS ASSIGNED TO DEPLETED MAIN BATTERIES AS A RESULT FROM USE/USER ERROR. THE MAIN BATTERIES WERE REPLACED IN ORDER TO CORRECT THIS CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. 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

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 814:01. IT IS UNKNOWN WHEN, OR IN WHICH CARE AREA, THIS EVENT OCCURRED. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS 6.13.90 - COLLEAGUE 2006.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1