BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP,COLLEAGUE SINGLE CHANNELCOLOUR

    MDR report key: 1970554 · Received January 25, 2011

    Report

    Report Number
    6000001-2011-00434
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    June 4, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE DEVICE WILL NOT BE REPAIRED FOR THE REPORTED CONDITION AT THIS TIME AS THIS IS A BAXTER-OWNED DEVICE. ADDITIONAL: THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, CATEGORIZED AS REMEDIATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE PRODUCT EVALUATION OF A COLLEAGUE INFUSION PUMP FOR ANOTHER REPORT, IT WAS DISCOVERED THAT FAILURE CODE 810:11 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. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP,COLLEAGUE SINGLE CHANNELCOLOUR PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1