BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2230256 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-21959
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER'S REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 570:320:844:0000 WAS CONFIRMED BY SERVICE. THE CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. THE PUMP WAS NOT REPAIRED AT THIS TIME BECAUSE IT IS A STAY-IN DEVICE OWNED BY BAXTER. THE PUMP IS IN BAXTER'S INVENTORY AND WILL BE REPAIRED AT A LATER DATE. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.03.00 WHICH IS CATEGORIZED AS UNREMEDIATED. THIS ISSUE HAS BEEN ESCALATED TO CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 570:320:844:0000; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS CONDITION WAS FOUND IN THE CRITICAL CARE UNIT. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. THE SOFTWARE VERSION IS CURRENTLY UNKNOWN AT THIS TIME. 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 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1