BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE-P1.7

    MDR report key: 2152776 · Received July 7, 2011

    Report

    Report Number
    6000001-2011-10745
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-08/04/10-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 804:26 WAS CONFIRMED BUT NOT REPRODUCED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY SOFTWARE FAILURE. HOWEVER, SINCE THIS CONDITION WAS NOT REPRODUCED, NO REPAIR WAS NECESSARY TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 804:26. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THE EVENT WAS REPORTED TO HAVE OCCURRED UPON POWER UP IN THE BIOMED SERVICE DEPARTMENT. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION REPORTED RELATED TO THE DEVICE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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