BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2141826 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-09005
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH THE TOP PART OF THE DISPLAY IS MISSING WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE A DEFECTIVE MAIN DISPLAY. APPROPRIATE ACTION WAS TAKEN TO CORRECT THE REPORTED PROBLEM BY REPLACING THE MAIN DISPLAY.A SOFTWARE HISTORY REVIEW FOUND THAT THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION.THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. 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 REPORTED A COLLEAGUE INFUSION PUMP THE TOP PART OF THE DISPLAY IS MISSING. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PREVENTATIVE MAINTENANCE IN BIOMED TESTING WITHIN THE BIOMED SERVICE DEPARTMENT. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.

    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