BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1862607 · Received October 8, 2010

    Report

    Report Number
    6000001-2010-03900
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K069636
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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). THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. ADDITIONAL: THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, CATEGORIZED AS REMEDIATED. BAXTER HAS CONDUCTED A SERVICE HISTORY REVIEW WHICH REVEALED THAT THE DEVICE HAS BEEN SERVICED PREVIOUSLY FOR THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH FILED, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PERCUTANEOUS CORONARY INTERVENTION ON (B)(6) 2010, OCCURRED IN THE PROXIMAL CIRCUMFLEX - FIRST OBTUSE MARGINAL ARTERY.

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP THAT HAD FAILURE CODE 810:11 THAT OCCURRED DURING INFUSION, WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE WAS PATIENT INVOLVEMENT. THE EVENT OCCURRED IN OB OBSTETRICS. 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 CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1