BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE-P1.7

    MDR report key: 2140136 · Received June 25, 2011

    Report

    Report Number
    6000001-2011-08877
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH VERTICAL LINES ON DISPLAY 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 SERVICE 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 HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF VERTICAL LINES IN DISPLAY. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT/USER INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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