BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2192197 · Received August 4, 2011

    Report

    Report Number
    6000001-2011-16645
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    April 30, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER?S REPORTED CONDITION OF AN INFUSION PUMP WITH DAMAGED BATTERY WAS CONFIRMED BY SERVICE. THE CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. THE PUMP WAS NOT REPAIRED AT THIS TIME AND WAS RETURNED TO INVENTORY. ADDITIONAL INFORMATION: THIS INVOLVED A REMEDIATED COLLEAGUE 2006 INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION, DAMAGED BATTERY.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO REPORTED PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SOFTWARE VERSION IS CURRENTLY 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