BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2162915 · Received July 15, 2011

    Report

    Report Number
    6000001-2011-12094
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPAIRED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN. THE CONDITION WAS CONFIRMED THROUGH A REVIEW OF THE EVENT HISTORY. THIS COMPLAINT IS AN ANCILLARY OF (B)(4). THE CAUSE WAS NOT IDENTIFIED AS THE CONDITION WAS NOT RELATED TO THE CUSTOMER REPORTED CONDITION. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE WAS INVESTIGATED BY A BAXTER FIELD SERVICE ENGINEER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE AWARE DATE IN THE INITIAL SUBMISSION WAS INCORRECT. THE MANUFACTURER AWARE DATE IS (B)(4) 2011.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED 67 DOWNSTREAM OCCLUSION SETS, WHICH INTERRUPTED DELIVERY. THESE ALARMS MAY HAVE BEEN A FALSE ALARMS. THERE WAS NO KNOWN PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    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