BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2170437 · Received July 21, 2011

    Report

    Report Number
    6000001-2011-13250
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 550:320:XXX WAS NOT CONFIRMED OR REPRODUCED BY BAXTER PERSONNEL DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS NOT IDENTIFIED. THE CUSTOMER DID NOT SEND THE PUMP IN FOR EVALUATION. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN SERVICED PRIOR TO THIS EVENT FOR THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE COMPLAINT LOT OR SERIAL NUMBER. DEVICE WAS NOT SENT IN FOR EVALUATION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 550:320. 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