BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2324204 · Received November 4, 2011

    Report

    Report Number
    6000001-2011-36200
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF CONSTANT AIR ALARM WAS NOT CONFIRMED DURING PRODUCT EVALUATION. HOWEVER, THE QUALITY ENGINEER IDENTIFIED AIR IN LINE ISSUE ON CHANNEL B TO BE THE PROBLEM. THE ROOT CAUSE WAS AN OUT OF CALIBRATIONS AIR IN LINE (AIL) PRINTED CIRCUIT BOARD (PCB). THE AIL PCB WAS RECALIBRATED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A "CONSTANT AIR ALARM" ISSUE. BAXTER QUALITY ENGINEERING DETERMINED THE PROBLEM TO BE AN AIR IN LINE ISSUE. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, HOWEVER, THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THIS DEVICE. THIS DEVICE IS A CAOLLEAGUE INFUSION PUMP WITH USER INTERFACE SOFTWARE MODULE VERSION 6.13.92. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1