BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2223651 · Received August 25, 2011

    Report

    Report Number
    6000001-2011-20690
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH AN AIR DETECTED SET ALARM WAS CONFIRMED DURING A REVIEW OF THE PUMP'S EVENT HISTORY, BUT IT WAS NOT DUPLICATED. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, THE PUMPHEAD MODULE WAS REPLACED. ADDITIONAL INFORMATION: THIS DEVICE IS A P1.5 COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.08.92. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY BY BAXTER (B)(4), A COLLEAGUE INFUSION PUMP EXPERIENCED AN AIR DETECTED SET ALARM WHICH CAUSED AN INTERRUPTION OF DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS 5.08.92. ON (B)(6) 2011, THE CUSTOMER CONTACTED BAXTER TO ADVISE THAT A COLLEAGUE VOLUMETRIC INFUSION PUMP, SN (B)(4), PRODUCT CODE (B)(4), ENCOUNTERED FAILURE CODE (FC) 814:04. IT IS UNKNOWN AT WHAT DATE, TIME, AND STAGE THE FAILURE OCCURRED; HOWEVER, THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THE DEVICE WILL BE RETURNED TO CTS FOR EVALUATION UNDER RGA# (B)(4). THIS ISSUE WAS ADDRESSED UNDER (B)(4). UPON REVIEW OF THE EVENT HISTORY REPORT FOR (B)(4) IT WAS FOUND THAT FC 814:04 CAUSED AN INTERRUPTION OF DELIVERY ON (B)(6) 2011. THIS IS A REPORTABLE MALFUNCTION. ADDITIONALLY, THE AIL BOARD WAS FOUND TO BE DEFECTIVE AND REQUIRED REPLACEMENT. THUS THE AIR DETECTED SET ALARMS WHICH CAUSED AN INTERRUPTION OF DELIVERY ON (B)(6) 2011 ARE ALL REPORTABLE MALFUNCTIONS. THIS COMPLAINT WILL ADDRESS THE SECOND AIR DETECTED SET ALARM WHICH OCCURRED ON (B)(6) 2011. PLEASE REFER TO ADDITIONAL COMPLAINTS (B)(4).

    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