BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP

    MDR report key: 1408329 · Received June 26, 2009

    Report

    Report Number
    6000001-2009-00609
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Date of Event
    June 17, 2009
    Report Date
    June 17, 2009
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF A PUMP IN WHICH THE STOP KEY ON THE PUMP HEAD MODULE (PHM) KEYPAD HAD STOPPED WORKING WAS CONFIRMED BY THE FACILITY'S BIOMEDICAL TECHNICIAN (BT). THE PHM KEYPAD WAS REPLACED; HOWEVER, WAS STILL NOT RESPONDING. THE BT IDENTIFIED THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) TO BE DEFECTIVE. THE BT HAS REQUESTED THE PART NUMBER FOR THE UIM PCB SO THE DEVICE CAN BE FIXED ON SITE. THE DEVICE WILL NOT BE RETURNED TO BAXTER FOR SERVICE EVALUATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) A COLLEAGUE INFUSION PUMP IN WHICH THE STOP KEY ON THE PUMP HEAD MODULE (PHM) KEYPAD STOPPED WORKING. THE FACILITY BIOMEDICAL TECHNICIAN STATED HE REPLACED THE PHM KEYPAD AND CHECKED THE CONNECTIONS. THE PHM KEYPAD WAS STILL NOT RESPONDING. THE BIOMEDICAL TECHNICIAN HAS IDENTIFIED THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) TO BE DEFECTIVE. THE BIOMEDICAL TECHNICIAN STATED THAT HE DOES NOT WANT TO SEND THE DEVICE IN FOR SERVICE EVALUATION, HOWEVER HAS REQUESTED THE PART NUMBER FOR THE UIM PCB SO THE DEVICE COULD BE NOT FIXED ON SITE. THIS PROBLEM WAS IDENTIFIED DURING BIO-MED TESTING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP NONE FRN BAXTER HEALTHCARE PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1