BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2172051 · Received July 22, 2011

    Report

    Report Number
    6000001-2011-13453
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 570:320:654 WAS NOT CONFIRMED DURING PRODUCT EVALUATION. ALSO, THE QUALITY ENGINEER HAS DETERMINED THE CAUSE TO BE NOT IDENTIFIED. SINCE NO ASSIGNABLE CAUSE WAS PROVIDED DURING PRODUCT EVALUATION, NO REPAIR WAS NECESSARY OR PERFORMED FOR THE REPORTED CONDITION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS FOUND DURING MANUFACTURING. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.09.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 570:320:654 , WHICH COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. THE REPORTED CONDITION OCCURRED DURING POWER UP IN THE BIOMED SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE SOFTWARE VERSION 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