BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2180594 · Received July 27, 2011

    Report

    Report Number
    6000001-2011-15070
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 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 EVENT DESCRIPTION INCORRECTLY LISTED THE LOOSE HARNESS AS BEING REPLACED, THIS HAS BEEN CHANGED TO THE CORRECT STATEMENT OF "A LOOSE HARNESS REQUIRING RE-INSERTION IN TO THE REAR HOUSING." THE DEVICE SERVICED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN, AND THE CONDITION WAS CONFIRMED. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF MASTER COMPLAINT (B)(4). THE CAUSE WAS DETERMINED TO BE A LOOSE MAIN SPEAKER HARNESS. TO CORRECT THE CONDITION, THE MAIN SPEAKER HARNESS WAS RE-INSERTED IN THE REAR HOUSING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY BEING EVALUATED ON-SITE 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.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A COLLEAGUE INFUSION PUMP REQUIRED THE REPLACEMENT OF A LOOSE MAIN SPEAKER HARNESS IN THE REAR HOUSING. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO 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