BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2161417 · Received July 13, 2011

    Report

    Report Number
    6000001-2011-11785
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 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). THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.08.92. EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY ALARM WAS CONFIRMED DURING ON-SITE PRODUCT EVALUATION. THE ROOT CAUSE OF THIS CONDITION WAS ASSIGNED TO DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THIS CONDITION. 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 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.

    Description of Event or Problem · 1

    A BAXTER FIELD SERVICE TECHNICIAN ADVISED THAT A COLLEAGUE DEVICE, PRODUCT CODE DNM8151, SERIAL # (B)(4) WAS SERVICED FOR A REPORT OF A BATTERY ISSUE. THE DATE OF INCIDENT AND THE PROCESS STEP ARE UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY/MEDICAL INTERVENTION. PATIENT INVOLVEMENT IS UNKNOWN. THE BAXTER FIELD SERVICE TECHNICIAN REPAIRED THE DEVICE ON SITE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO CANADIAN TECHNICAL SERVICES. THE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.

    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