BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2172558 · Received July 22, 2011

    Report

    Report Number
    6000001-2011-13488
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP WAS NOT AVAILABLE FOR EVALUATION AS THE CUSTOMER DID NOT RETURN THE PUMP TO BAXTER. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THERE HAVE BEEN PREVIOUS REPORTED PROBLEMS WITH THIS DEVICE THAT ARE THE SAME AS OR SIMILAR TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING ONE EXCEPTION DURING MANUFACTURING, HOWEVER, THE DEVICE WAS RE-TESTED AND FOUND TO BE PERFORMING AS DESIGNED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP 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