BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2212537 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-19004
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 WAS CONFIRMED DURING PRODUCT EVALUATION. HOWEVER, THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE NOT IDENTIFIED. THEREFORE, NO REPAIRS HAVE BEEN MADE AT THIS TIME. 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 810.11, WHICH COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. IT IS UNKNOWN IF THERE WAS 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 - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1