BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1901706 · Received November 17, 2010

    Report

    Report Number
    6000001-2010-04932
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    August 15, 2010
    Report Date
    October 25, 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, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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). A DEVICE HISTORY REVIEW HAS BEEN PERFORMED AND THERE WERE NO EXCEPTIONS NOTED DURING THE MANUFACTURING OF THIS PRODUCT. A TREND REVIEW HAS BEEN PERFORMED AND THERE HAVE BEEN SIMILAR REPORTS MADE TO BAXTER. THE ROOT CAUSE IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. THIS IS A STAY-IN UNIT AND WILL NOT BE REPAIRED AT THIS TIME. ADDITIONAL: A SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED BY BAXTER PRIOR TO THIS EVENT. BAXTER HAS PERFORMED A DEVICE HISTORY REVIEW AND IT REVEALED THAT THERE WERE NO EXCEPTIONS ASSOCIATED WITH THE MANUFACTURING OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING BAXTER'S REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT OF A COLLEAGUE INFUSION PUMP, 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 5.09.90, CATEGORIZED AS REMEDIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1