BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT

    MDR report key: 1780084 · Received August 2, 2010

    Report

    Report Number
    6000001-2010-02318
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND EVALUATED BY BAXTER. THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE IS A FAULTY PHM (PUMPHEAD MODULE). THE PHM HAS BEEN REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH MULTIPLE DOWNSTREAM OCCLUSION ERRORS. THE DEVICE WAS REPORTED TO HAVE COME FROM THE (B)(6) INTENSIVE CARE UNIT HOWEVER, THE CONDITION WAS REPORTED TO HAVE BEEN FOUND DURING BIOMEDICAL TESTING. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. DURING PRODUCT EVALUATION AT BAXTER, IT WAS DISCOVERED THAT THE EVENT OCCURRED DURING DELIVERY. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.90 WHICH IS CATEGORIZED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1