BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2230216 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-21938
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS NOT SENT TO BAXTER FOR DEVICE EVALUATION OR REPAIR. THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED NOR CAN AN ASSIGNABLE CAUSE BE PROVIDED. SHOULD THIS PUMP BE RECEIVED BY BAXTER FOR EVALUATION, OR IF ANY ADDITIONAL INFORMATION ABOUT THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS NOT AVAILABLE, SINCE CUSTOMER IS NOT SENDING IN THE DEVICE FOR EVALUATION. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN SERVICED PRIOR TO THIS EVENT. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE COMPLAINT LOT OR SERIAL NUMBER. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CALL WAS RECEIVED BY PRODUCT SURVEILLANCE FROM A (B)(4) TECHNICAL SERVICE ASSOCIATE. THE TECHNICAL SERVICE ASSOCIATE STATED THAT HE HAD RECEIVED AN EMAIL FROM THE FACILITY STATING THAT A COLLEAGUE INFUSION PUMP HAD FAILED A DOWNSTREAM OCCLUSION TEST WITH THE MINIMUM PRESSURE SELECTED. THIS CONDITION HAS THE POTENTIAL TO BE A FALSE ALARM. IT IS UNKNOWN DURING WHAT PROCESS STEP THIS EVENT OCCURRED, HOWEVER, IT IS KNOWN TO HAVE OCCURRED IN THE BIOMED SERVICE DEPARTMENT. THERE WAS NO REPORT OF PATIENT/USER INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1