BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2122468 · Received June 13, 2011

    Report

    Report Number
    6000001-2011-07602
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 THE MALFUNCTION OF CAN'T LOAD SOFTWARE WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE ISOCOM PRINTED CIRCUIT BOARD (PCB). THE ISOCOM PCB WAS REPLACED TO CORRECT THIS CONDITION. 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 MALFUNCTION OF CAN'T LOAD SOFTWARE. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THE EVENT WAS REPORTED TO HAVE OCCURRED UPON POWER UP, WHILE IN THE BIOMED SERVICE DEPARTMENT. THERE WAS NO REPORT OF PATIENT/USER INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE SOFTWARE VERSION 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