BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1963428 · Received January 19, 2011

    Report

    Report Number
    6000001-2011-00331
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:04 ON CHANNEL A WAS CONFIRMED IN THE PUMP'S EVENT HISTORY BY A BAXTER SERVICE TECHNICIAN. THIS CONDITION WAS CAUSED BY A DEFECTIVE AIR IN LINE (AIL) PRINTED CIRCUIT BOARD (PCB). THE AIL PCB WAS REPLACED TO CORRECT THIS CONDITION. UPON FURTHER REVIEW OF THE EVENT HISTORY, THE OCCURRENCE DATE OF THIS EVENT WAS DETERMINED TO BE (B)(6) 2010. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.03.00. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. 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 (B)(4).

    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.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:04 ON CHANNEL A. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. UPON REVIEWING THE PUMP'S EVENT HISTORY, A BAXTER SERVICE TECHNICIAN DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    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