BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2183290 · Received July 28, 2011

    Report

    Report Number
    6000001-2011-15405
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A LOW BATTERIES WAS CONFIRMED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE WAS A BATTERY LOW SET ALARM. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THE REPORTED CONDITION. THE USER INTERFACE MODULE SOFTWARE VERSION IS 6.63.92.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON SITE BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. 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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A BATTERY ISSUE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1