BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDSYSTEM III INFUSION PUMP

    MDR report key: 2612676 · Received June 6, 2012

    Report

    Report Number
    2016493-2012-00256
    Event Type
    Death
    Date Received
    June 6, 2012
    Date of Event
    May 11, 2012
    Report Date
    May 14, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K933545
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE INFUSION DEVICE HAS BEEN RECEIVED BUT DISPOSABLE TUBING WAS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION IS PENDING AND FOLLOW UP REPORT WILL BE SUBMITTED ONE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT INVOLVING 2 MSIII PUMPS. THE DETAILS OF THE EVENT ARE AS FOLLOWS: A VENTILATED PT WITH MULTISYSTEM FAILURE WAS BEING TRANSPORTED TO A TERTIARY FACILITY. THE PT WAS ON MSIII PUMP (SN (B)(4)) WHICH WAS INFUSING DOBUTAMINE 500 MG/250 CC AT 5 MCG/KG/MIN OR 21 CC/HR (CHANNEL A) AND LEVOPHED 4 MG/250 CC AT 0.1 MCG/KG/MIN OR 56.3 CC/HR (CHANNEL B). APPROXIMATELY 18 MINUTES AFTER INITIATING THE INFUSIONS, CHANNEL B DISPLAYED AN AIR SENSOR ERROR MESSAGE. ATTEMPTS TO CLEAR THE ERROR WERE UNSUCCESSFUL. MEDICATION WAS THEN TRANSFERRED TO CHANNEL C WHICH ALARMED FOR JAMMED CASSETTE. CHANNEL C WAS INSPECTED FOR PROPER CASSETTE INSERTION AND A NEW SET WAS RE-INSERTED. AT THIS TIME A ¿FAULT¿ NOTIFICATION OCCURRED WITH CONTINUOUS ALARMS. ¿THE ¿RETRY/SERVICE BUTTONS¿ DISPLAYED ON PUMP.¿ THE PUMP COULD NOT BE RESTARTED AND THE PUMP STOPPED INFUSING MEDICATIONS. A SECOND MSIII PUMP (SN (B)(4)) WAS ACCESSED AND POWERED ON WITHOUT INITIALLY ALARMING. WHEN PREPARING TO INSERT CASSETTE INTO CHANNEL A, THE CHANNEL ALARMED FOR ¿FAULT¿. THE CASSETTE WAS INSTEAD INSERTED INTO CHANNEL B AND THE PUMP ALARMED FOR MAINTENANCE ON ALL 3 CHANNELS. ATTEMPTS TO TROUBLESHOOT WERE DISCONTINUED DUE TO PT CONSIDERATIONS. THE CUSTOMER STATED THAT BOTH PUMPS HAD JUST BEEN TAKEN OFF THE CHARGING STATION AND THAT THERE WERE NO PUMP COMPLICATIONS RELAYED AND NO INITIAL OPERATIONAL CHECKS WERE PERFORMED BY ONGOING CREW. THE PT QUICKLY BECAME HYPOTENSIVE SO LEVOPHED WAS ADMINISTERED WIDE OPEN VIA GRAVITY. THE PT WAS TAKEN BACK TO THE EMERGENCY ROOM AT WHICH TIME THE PT SUFFERED A CARDIAC ARREST. THE CUSTOMER STATED THE PT WAS NOT REVIVED AND THE ETIOLOGY IS UNKNOWN. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: BOTH CHANNELS A AND B INITIATED WITHOUT COMPLICATIONS. APPROXIMATELY 18 MINUTES AFTER INITIATING, CHANNEL B SUFFERS AN ALARM ACTIVATION FOR AN AIR SENSOR. UNSUCCESSFUL WITH FOUR (4) ATTEMPTS TO CLEAR AIR SENSOR ALARM BY REMOVING CASSETTE, FLUSHING LINE, AND RE-INSERTING. MEDICATION IS THEN TRANSFERRED FROM CHANNEL B TO CHANNEL C, RESTART ATTEMPTED. ALARM NOW IN CHANNEL C FOR CASSETTE JAMMED. CASSETTE REMOVED AND REINSERTED, NOW WITH A NOTIFICATION TO ¿PRESS IN CASSETTE.¿ BOTH CREW MEMBERS INSPECTED CASSETTE FOR PROPER INSERTION. NEXT, THE CASSETTE IS REMOVED AND AN ENTIRE NEW FULL SET IS PRIMED AND RE-INSERTED INTO CHANNEL C. AT THIS TIME A FAULT NOTIFICATION ABOVE CHANNEL A WITH CONTINUOUS ALARMS. DESPITE ATTEMPTS TO RESTART CHANNELS B OR C, A BRIEF FLASH OF THE GREEN LIGHT, AND THEN PUMP STOPS WITHOUT INFUSING ANY FURTHER MEDICATION. TWO BUTTONS PRESENT FOR ¿RETRY, OR SERVICE.¿ RETRY IS ATTEMPTED WITHOUT ANY SUCCESS TO TROUBLESHOOT ALARM. SERVICE BUTTON IS THEN PRESSED IN ATTEMPTS TO CLEAR, AND NOW LOCKS OUT ALL THREE CHANNELS FROM ANY CHANGES. DURING THE PREVIOUS TROUBLESHOOT ATTEMPTS FROM FAULT NOTIFICATION, A SECOND ALARIS MEDICAL SYSTEMS IVAC MINIMED TRIPLE CHANNEL INFUSION PUMP WAS RETRIEVED FROM EQUIPMENT BAG. PUMP POWERED ON WITHOUT ALARM FOR NEARLY 15-20 SECONDS. WHEN PREPARING TO INSERT CASSETTE INTO CHANNEL A, ALARM FOR FAULT AGAIN ACTIVATES WITH FAULT ABOVE CHANNEL A. CASSETTE INSERTED INTO CHANNEL B. ALARM ACTIVE WITH DISPLAY TO CALL ALARIS FOR MAINTENANCE WHICH IS CLEARED TO OBTAIN STANDARD DISPLAY. ONCE IN STANDARD VIEW, ACTIVE FAULT ALARM CONTINUES WITH ALL LIGHTS BLINKING RED. BOTH PUMPS ARE UNABLE TO BE SUCCESSFULLY LOADED AND STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDSYSTEM III INFUSION PUMP FRN CAREFUSION CORPORATION 2865 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death MEDSYSTEM III INFUSION PUMP ADMINISTRATION SET:| MODEL 28034E, LOT # 11025271| VENTILATOR: MFR, MODEL & LOT # UNKNOWN