BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1884280 · Received October 27, 2010

    Report

    Report Number
    6000001-2010-04556
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    June 14, 2010
    Report Date
    October 5, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS DEPLETED BATTERIES. THE BATTERIES HAVE BEEN REPLACED. ADDITIONAL: THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.06.00, CATEGORIZED AS UNREMEDIATED. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING BAXTER'S REVIEW OF THE EVENT HISTORY OF ANOTHER REPORT FOR A COLLEAGUE INFUSION PUMP, IT WAS DISCOVERED THAT A BATTERY DEPLETED SET ALARM 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 COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1