BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2221798 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20555
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    May 23, 2006
    Report Date
    August 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4.) FOR INFORMATION REGARDING THE FACILITY'S MEDWATCH, PLEASE SEE THE ATTACHED FACILITY REPORT. A REQUEST FOR THE RETURN OF THE DEVICE WILL BE ATTEMPTED; HOWEVER, IT IS UNKNOWN IF THE CUSTOMER STILL HAS THIS DEVICE. 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. PLEASE REFER TO ATTACHED FACILITY REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP THAT FAILED WHILE BEING SET UP WAS NOT CONFIRMED OR DUPLICATED BY BAXTER SERVICE PERSONNEL BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION BY THE CUSTOMER. NO CAUSE COULD BE DETERMINED AND NO REPAIRS WERE NEEDED. IT IS NOT KNOWN WHAT USER INTERFACE MODULE SOFTWARE CONFIGURATION THE DEVICE HAD. A DEVICE HISTORY REVIEW REVEALED NO ABNORMALITIES WERE FOUND DURING MANUFACTURING. THE DEVICE HAS NOT BEEN SENT IN FOR SERVICE PREVIOUSLY; THEREFORE, NO SERVICE HISTORY WAS AVAILABLE FOR THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN A MEDWATCH REPORT RECEIVED BY PRODUCT SURVEILLANCE, A CUSTOMER REPORTED THAT "WHILE SETTING THE PUMP UP TO BE USED, THE PUMP FAILED". THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION REPORTED. 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 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1