BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1982992 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00804
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - WAUKEGAN
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF AIR DETECTED ALARM EVEN WHEN THERE IS NO AIR WAS CONFIRMED BUT NOT DUPLICATED. THE ROOT CAUSE WAS DETERMINED TO BE THE AIR IN LINE PRINTED CIRCUIT BOARD BEING OUT OF CALIBRATION. NO REPAIRS HAVE BEEN PERFORMED AT THIS TIME SINCE THIS IS A BAXTER OWNED DEVICE. ADDITIONAL INFORMATION: THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED. A SERVICE HISTORY REVIEW REVEALED THAT THERE WERE NO PREVIOUS SERVICE EVENTS RELATED TO THE REPORTED CONDITION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    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. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF AIR IN LINE - FALSE ALARM. (B)(4)

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH AN AIR DETECTED ALARM WHEN THERE WAS NO AIR. THE REPORTED CONDITION OCCURRED DURING DELIVERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1