BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2182548 · Received July 28, 2011

    Report

    Report Number
    6000001-2011-15265
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION, DEFECTIVE SCREEN/TROUBLE WITH THE DISPLAY, WAS NOT CONFIRMED BY SERVICE. HOWEVER, SPOTS WERE FOUND ON THE MAIN DISPLAY AND BAXTER QUALITY ENGINEER DETERMINED THIS CONDITION WAS RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE DETERMINED CONDITION WAS NOT IDENTIFIED. THE MAIN DISPLAY WAS REPLACED TO FIX THE DETERMINED CONDITION. THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.63.92.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. UPON COMPLETION OF BAXTER?S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A DEFECTIVE SCREEN/TROUBLE WITH THE DISPLAY, WHICH COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. PATIENT INVOLVEMENT WAS NOT REPORTED. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. THE SOFTWARE VERSION FOR THE DEVICE IS CURRENTLY NOT KNOWN. 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