BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1860658 · Received October 7, 2010

    Report

    Report Number
    6000001-2010-03797
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF FAILURE CODE 814:04. THE ROOT CAUSE COULD NOT BE DETERMINED. NO REPAIRS WERE PERFORMED ON THIS BAXTER OWNED DEVICE. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION OCCURRED ON (B)(6) 2010 AND NOT THE ORIGINALLY REPORTED OCCURRENCE DATE OF (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    (B)(4), A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED FAILURE CODE 814:04. IT IS UNKNOWN WHEN OR AT WHAT POINT IN THE PROCESS THIS CONDITION OCCURRED. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THIS CONDITION INTERRUPTED DELIVERY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, WHICH IS CLASSIFIED AS REMEDIATED. 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 - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1