BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3-INFUSION PUMP

    MDR report key: 1977888 · Received February 3, 2011

    Report

    Report Number
    6000001-2011-00619
    Event Type
    Death
    Date Received
    February 3, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A 510(K) NUMBER WILL NOT BE PROVIDED AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. BAXTER REQUESTED AND RECEIVED THE DEVICE FOR EVALUATION BY THE PRODUCT ANALYSIS LAB (PAL). UPON COMPLETION OF THE EVALUATION A FOLLOW UP REPORT WILL BE SUBMITTED. THE SOFTWARE VERSION FOR THE DEVICE IS: UIM SOFTWARE VERSION 5.48.92

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: EVENT DESCRIPTION (BELOW). ADDITIONAL INFORMATION WAS RECEIVED BY THE NURSE WHO REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 WITH A SUBDURAL HEMORRHAGE. THE PATIENT REMAINED HOSPITALIZED UNTIL THE TIME OF DEATH ON (B)(6) 2011. SHE REPORTED THAT ON (B)(6) 2011 DURING TRANSPORT TO THE ICU, THE CHANNEL ON THE PUMP WHICH WAS MANAGING THE NORADRENALINE STOPPED SUDDENLY AND WAS STUCK ON THE MAIN DISPLAY. THERE WAS AN ATTEMPT MADE TO CHANGE THE CHANNEL TO MAINTAIN THE NORADRENALINE INFUSION. HOWEVER, THE CHANNEL DID NOT RESPOND TO THE COMMAND. THE NURSE REPORTED THAT THIS CAUSED SEVERE HEMODYNAMIC INSTABILITY IN THIS PATIENT. NO FURTHER INFORMATION WAS AVAILABLE. EVALUATION: THE EVENT HISTORY REVIEW SHOWED THAT THE PUMP DETECTED AIR IN LINE. THE USER WAS UNABLE TO CLEAR THE AIR IN LINE, AND THE KEYS WERE UNRESPONSIVE DUE TO THE LOCK BUTTON BEING PRESSED, LOCKING OUT THE KEYS. THE USER NEEDED TO PRESS LOCK BUTTON AGAIN TO UNLOCK THE KEYS. ONCE THE LOCK BUTTON WAS PRESSED, THE USER WAS ABLE TO REGISTER KEY PRESSES. THERE IS NO INDICATION THAT THE PUMP POWERED OFF BY ITSELF (SILENT SHUTDOWN). THE EVENT HISTORY SHOWS AN OFF KEY PRESS. QUICK FREE INFUSIONS WERE PERFORMED TO TEST THE PRODUCT AND NO DEVIATION WAS FOUND. THE PUMP WAS TESTED ACCORDING TO PROCEDURE AND ALL RESULTS WERE SATISFACTORY. AFTER THAT, THE PUMP WAS CALIBRATED AND THE RESULTS WERE WITHIN SPECIFICATION LIMITS. DURING THE EVALUATION THE PUMP DID NOT STOP OR LOCK. THERE WAS NO FAILURE OR SYSTEM ERROR OBSERVED ON THE EVENT LOG AND ALL TESTS PERFORMED PRESENTED RESULTS WITHIN SPECIFICATION LIMITS. THEREFORE, THE ISSUE WAS NOT CONFIRMED AND THE ROOT CAUSE WAS NOT DETERMINED. NO CORRECTIVE ACTION WAS REQUIRED. AS NO DEVIATION WAS OBSERVED ON THE PUMP, IT WAS RELEASED AND RETURNED TO CUSTOMER. THE LAST TWO TIMES THAT THE MACHINE WAS SERVICED WERE (B)(6) 2009 DUE TO A REPAIR NOT RELATED TO POWERED OFF AND ON (B)(6) 2010 DUE A PREVENTIVE MAINTENANCE. THERE ARE NO SIMILAR REPORTS FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER IN (B)(6) OF A HYPOVOLEMIC PATIENT WHO WAS RECEIVING NORADRENALIN VIA A COLLEAGUE 3-INFUSION PUMP WHEN AN INTERRUPTION OF INFUSION OCCURRED. DUE TO THE INFUSION INTERRUPTION THE PATIENT REMAINED IN SEVERE SHOCK AND MEDICAL INTERVENTION(S) WERE REQUIRED. IT WAS NOT REPORTED WHETHER THE PATIENT RECOVERED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3-INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R NORADRENALIN