BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP-COLLEAGUE 3

    MDR report key: 1932572 · Received December 18, 2010

    Report

    Report Number
    6000001-2010-05972
    Event Type
    Death
    Date Received
    December 18, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - IF THE DEVICE SHOULD BECOME AVAILABLE FOR EVALUATION, A FOLLOW UP WILL BE SUBMITTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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. IT HAS BEEN CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE. THE HOSPITAL REFUSES TO SUPPLY THE PATIENT INFORMATION. THE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). NO OBSERVATION OF 'UNINTENDED SHUTDOWN' WAS SEEN DURING INVESTIGATION/TESTING OF THE PUMP. FAILURE CODE 804:26 WAS RECORDED IN THE EVENT HISTORY FOR CHANNEL A SEVERAL TIMES; THIS FAILURE CODE DID NOT RE-OCCUR DURING THE INVESTIGATION/TESTING OF THE PUMP. THIS FAILURE CODE CAN BE GENERATED BY THE USER IF THE DEVICE HAS BEEN POWERED ON AND THE MANUAL TUBE RELEASE USED BEFORE THE COMPLETION OF THE SPEAKER TEST. PER THE SERVICE HISTORY REVIEW, THE DEVICE HAS NOT BEEN RETURNED FOR REPAIRS. THE DEVICE HISTORY REVIEW REVEALED THERE WERE NO CHANGES TO THE MANUFACTURING PROCESS THAT COULD BE ATTRIBUTED TO THE REPORTED CONDITION. THE ROOT CAUSE OF THE UNINTENDED SHUT DOWN WAS UNDETERMINED. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.92 CATEGORIZED AS REMEDIATED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON 24NOV2010, A QUALITY MANAGER OF (B)(4) HEALTH CARE SUPPLY COMPANY (B)(4), BAXTER'S DISTRIBUTOR IN (B)(4), RECEIVED NOTIFICATION FROM (B)(6) UNIVERSITY HOSPITAL THAT ONE BAXTER COLLEAGUE TRIPLE CHANNEL PUMP AUTOMATICALLY SHUT DOWN TWICE DURING THE INFUSION PERIOD.THE PATIENT EXPIRED LATER THAT NIGHT. THE ACTUAL DEVICE WAS EVALUATED ON 22NOV2010 BY A BIOMED SERVICE ENGINEER AT (B)(4) AND FOUND NO SHUT DOWN EVENTS IN THE EVENT LOG, AND THE PUMP FUNCTIONED NORMALLY. ON 24NOV2010, THE (B)(4) SERVICE ENGINEER RECEIVED ADDITIONAL INFORMATION FROM THE (B)(6) INTENSIVE CARE UNIT NURSE WHO WAS IN CHARGE THE NIGHT OF THE EVENT. THE CHARGE NURSE INDICATED THAT BAXTER WAS NOT TO BLAME. SHE STATED THAT THE PATIENT WAS NOT CONNECTED TO THIS COLLEAGUE PUMP AT THE TIME OF DEATH. AFTER THE DOUBLE AUTOMATIC SHUTDOWN OF THIS COLLEAGUE PUMP, IT WAS SWAPPED FOR A DIFFERENT INFUSION PUMP. THE SERIAL NUMBER OF THE PUMP CONNECTED TO THE PATIENT AT THE TIME OF DEATH IS NOT RECORDED, AND WAS STILL IN USE IN THE ICU. THE HOSPITAL HAS NOT LOCATED IT. THE HOSPITAL REFUSES TO REVEAL THE PATIENT'S DEMOGRAPHICS, DIAGNOSIS, CLINICAL HISTORY AND CONCOMITANT THERAPY INFORMATION. INDICATIONS FOR THE INFUSION, PATIENT'S CLINICAL CONDITION BEFORE THE SHUT DOWN AND CAUSE OF DEATH WERE UNKNOWN, AS IS ANY AUTOPSY THAT WAS PERFORMED. THIS PUMP IS P1.5 SYSTEM SOFTWARE, LAST SERVICED 09 MAY 2010 AT (B)(4) TECHNICAL CENTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death