BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2141812 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-08992
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 807:05 WAS CONFIRMED DURING PRODUCT EVALUATION IN THE PUMP'S EVENT HISTORY BUT NOT DUPLICATED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. THERE WAS NO REPAIR NECESSARY TO CORRECT THIS CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED 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 FAILURE CODE 807:05. THE REPORTED CONDITION OCCURRED DURING BIO-MED TESTING. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SOFTWARE VERSION IS CURRENTLY NOT KNOWN.

    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