BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2141937 · Received June 28, 2011

    Report

    Report Number
    6000001-2011-09059
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAULTY DISPLAY THAT HAS THE BOTTOM HALF OF SCREEN DUPLICATING CHARACTERS WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY A DEFECTIVE MAIN DISPLAY. THE MAIN DISPLAY WAS REPLACED TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THIS PUMP HAS NEVER PREVIOUSLY BEEN SENT TO BAXTER FOR SERVICE AND, THEREFORE, THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS DURING MANUFACTURING FOUND. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). THIS INVOLVED A COLLEAGUE VERSION P1.7 INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 8.11.00.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO BAXTER (B)(4) A COLLEAGUE INFUSION PUMP WITH A FAULTY DISPLAY; THE BOTTOM HALF OF SCREEN DUPLICATES CHARACTERS. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO REPORT OF 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 PUMP IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1