BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 2021489 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01924
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 28, 2010
    Report Date
    February 28, 2010
    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). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CORRECT AWARE DATE FOR THIS REPORT IS 28 FEB 2011, NOT 28 FEB 2010 AS ORIGINALLY REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP THAT FAILED TO ALARM FOR AN OCCLUSION DURING TESTING BY BAXTER COULD NOT BE DUPLICATED DURING FURTHER PRODUCT EVALUATION. THEREFORE, NO ASSIGNABLE CAUSE CAN BE PROVIDED. HOWEVER, THE CHANNEL C PUMPHEAD MODULE WAS REPLACED AS A PRECAUTION. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A BAXTER SERVICE TECHNICIAN DISCOVERED A COLLEAGUE INFUSION PUMP WITH AN OCCLUSION ALARM. THIS PROBLEM WAS IDENTIFIED DURING SERVICE AND FAILED TO ALARM AS THE PUMP WAS BEING TESTED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.03.00.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1