BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2212271 · Received August 15, 2011

    Report

    Report Number
    6000001-2011-18914
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH "NOISY FAN/POWER SUPPLY" WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS DETERMINED TO BE A DAMAGED FAN ASSEMBLY INSIDE THE REAR CASE. HOWEVER, NO REPAIRS HAVE BEEN PERFORMED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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. THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. 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

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A "NOISY FAN/POWER SUPPLY." IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS INVOLVED A COLLEAGUE VERSION 1.7 INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 7.01.00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1