BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2260807 · Received September 22, 2011

    Report

    Report Number
    6000001-2011-26413
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    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 DEVICE WAS RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED BY SERVICE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS DETERMINED TO BE THAT THE USER PERSONALITY FEATURE SET (PFS) WAS SET TO A RATE BELOW 100ML OR A VOLUME BELOW 20ML. THIS FAILURE CODE IS ASSOCIATED WITH THE VALUES FOR VOLUME BEING LESS IN THE ACTIVE PFS THAN THE VALUES IN THE FUNCTIONAL TEST MODE (FTM) WHEN ENTERING FTM FROM WITHIN A PFS OR WHEN PRESSING THE START KEY DURING FTM. TO CORRECT THIS CONDITION, THE DEFAULT PFS WAS CHANGED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING A PRODUCT EVALUATION BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP EXPERIENCED FAILURE CODE 18:115:885:03E8, WHEN ENTERING THE FUNCTIONAL TEST MENU. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. "THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT." THIS INVOLVED A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1