BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2212544 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-19007
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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). DEVICE EVALUATION: THE REPORTED CONDITION WAS NOT CONFIRMED, AS THE REPORTED CONDITION WAS NOT REPRODUCED. THE ASSIGNABLE CAUSE COULD NOT BE IDENTIFIED. NO REPAIRS WERE PERFORMED FOR THE REPORTED CONDITION DUE TO ESTIMATE REFUSAL BY THE CUSTOMER. (B)(4). THE USER INTERFACE MODULE SOFTWARE VERSION IS 5.04.00 BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A "CHANNEL A IS DIM" MALFUNCTION. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED IN BIOMED SERVICE. 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. THE USER INTERFACE MODULE SOFTWARE VERSION IS UNKNOWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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