BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 2012432 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01743
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF FAILED TO ALARM FAILURE CODE 550:320:654 WAS CONFIRMED THROUGH EVALUATION. THIS CONDITION IS DUE TO A DISCONNECTED MAIN SPEAKER HARNESS. THE MAIN SPEAKER HARNESS WAS RECONNECTED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THERE IS AN ONGOING CAPA INVESTIGATION, MDQ-CAPA (B)(4) ASSOCIATED WITH THIS REPORT. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "550:XXX." (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 550:324:654:0000. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THE HOSPITAL REPRESENTATIVE DID NOT HAVE ANY INFORMATION ON PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING DEVICE EVALUATION BY BAXTER THE DEVICE FAILED TO ALARM FAILURE CODE 550:320:654. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.04.00 CATEGORIZED AS UNREMEDIATED.

    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