BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2181739 · Received July 27, 2011

    Report

    Report Number
    6000001-2011-15140
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF ?BROKEN PUMP HEAD MODULE? WAS NOT CONFIRMED DURING PRODUCT EVALUATION; HOWEVER, VISUAL INSPECTION FOUND A BROKEN PUMP HEAD MODULE ON CHANNEL A AND CHANNEL B. THE ROOT CAUSE OF THIS CONDITION WAS A DEFECTIVE PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED IN ORDER TO CORRECT THIS CONDITION. THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.92.

    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. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A BROKEN PUMP HEAD MODULE. THE REPORTED CONDITION OCCURRED BEFORE USE. PATIENT INVOLVEMENT WAS NOT REPORTED. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. THE SOFTWARE VERSION FOR THIS DEVICE CURRENTLY IS NOT KNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE FOR EVALUATION.

    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