BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2192795 · Received August 5, 2011

    Report

    Report Number
    6000001-2011-16764
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE AIL (AIR IN LINE) BOARD OUT OF CALIBRATION. APPROPRIATE ACTION WAS TAKEN TO CORRECT THE REPORTED PROBLEM BY RECALIBRATING THE AIL BOARD. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "FAILURE CODE 810:11".

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND IS AVAILABLE FOR EVALUATION. 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

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP IN WHICH FAILURE CODE 8010:11 OCCURRED. THIS CONDITION HAS THE POTENTIAL TO CAUSE AN INTERRUPTION OF DELIVERY. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, CATEGORIZED AS REMEDIATED. THERE IS NO FURTHER COMPLAINT INFORMATION 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