BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1904888 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05056
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    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). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER?S REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH "AIR ALARM ON CHANNEL A" WAS CONFIRMED BUT NOT DUPLICATED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY THE PUMP'S AIR IN LINE (AIL) PRINTED CIRCUIT BOARD (PCB) BEING OUT OF CALIBRATION. THE AIL PCB WAS CALIBRATED TO CORRECT THIS CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH "AIR ALARM ON CHANNEL A". THIS EVENT MAY HAVE BEEN A FALSE AIR-IN-LINE ALARM. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. IT IS CURRENTLY UNKNOWN IF THERE WAS PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. HOWEVER, MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1