BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE-P1.7

    MDR report key: 2140142 · Received June 25, 2011

    Report

    Report Number
    6000001-2011-08898
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON-SITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN. 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 DEVICE WAS REPAIRED ON-SITE AT THE CUSTOMER FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN, AND THE CONDITION WAS CONFIRMED. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE IS UNKNOWN. NO REPAIRS WERE MADE TO CORRECT THE REPORTED CONDITION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER SERVICE PERSONNEL, A COLLEAGUE INFUSION PUMP EXPERIENCED A BATTERY DEPLETED SET ALARM. THIS CONDITION MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.

    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