BEUDAMED
    FDA Adverse Event Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 2003275 · Received February 28, 2011

    Report

    Report Number
    6000001-2011-01426
    Date Received
    February 28, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF FAILURE CODE 703:00 WAS NOT CONFIRMED DURING PRODUCT EVALUATION; HOWEVER, THE QUALITY ENGINEER HAS IDENTIFIED FLUID INTRUSION ON THE PUMP HEAD MODULE (PHM) PRINTED CIRCUIT BOARD (PCB) AS THE CAUSE OF THE REPORTED CONDITION. THE CHANNEL A PHM AND "UIM" PCB WERE REPLACED TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE BAXTER SERVICE TECHNICIAN REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED FAILURE CODE 703:00 DURING DEVICE EVALUATION. THIS CONDITION INTERRUPTED DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. THIS A USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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