BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2200387 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18083
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DISPLAY MALFUNCTION WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY A DEFECTIVE MAIN DISPLAY. THE MAIN DISPLAY WAS REPLACED TO CORRECT THIS CONDITION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A DISPLAY MALFUNCTION, WHICH COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. THE REPORTED CONDITION OCCURRED UPON POWER UP IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE SOFTWARE VERSION FOR THIS 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 - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1