BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP CE FRENC

    MDR report key: 1901770 · Received November 17, 2010

    Report

    Report Number
    6000001-2010-04941
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    May 17, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS A DEFECTIVE UIM (USER INTERFACE MODULE) BOARD. THE UIM BOARD HAS BEEN REPLACED. THE DEVICE HAS BEEN EVALUATED AND REPAIRED ONSITE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A TREND REVIEW HAS BEEN PERFORMED AND THERE HAVE BEEN SIMILAR REPORTS MADE TO BAXTER. THE ROOT CAUSE INVESTIGATION WILL CONTINUE TO BE INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Description of Event or Problem · 1

    DURING BAXTER (B)(4) REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT OF A COLLEAGUE INFUSION PUMP, IT WAS DISCOVERED THAT FAILURE CODE 403:317:839:0000 OCCURRED DURING INFUSION WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.06.00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP CE FRENC PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1