BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6189494 · Received December 20, 2016

    Report

    Report Number
    2016493-2016-00963
    Event Type
    Death
    Date Received
    December 20, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 22, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICES HAVE BEEN RECEIVED AND THE INVESTIGATION IS IN-PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTION ON FOLLOW-UP (1): ( EVALUATION CONCLUSION). THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE OF DEVICES SHUT DOWN DURING AN INFUSION WAS NOT IDENTIFIED, HOWEVER THE LOG SHOWS THAT THE TWO PUMP MODULES THAT WERE IN USE WERE CHANNELED OFF BY THE USER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED: WEIGHT. THE CUSTOMER¿S REPORT THAT DEVICES SHUT DOWN DURING AN INFUSION WAS NOT CONFIRMED. PHYSICAL INSPECTION NOTED THE DEVICE TO BE IN OVERALL FAIR CONDITION WITH THE INSTRUMENT SEAL INTACT. THE ONLY OBSERVED ANOMALIES WERE A CRACK AT THE LOWER DOOR HINGE AND DULL IUI CONNECTORS. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT AT 01:48 ON (B)(6) 2016 A BASIC INFUSION WAS STARTED AT 100 ML/HR WITH A VTBI OF 50 ML. AT 01:53 THE DEVICE ALARMED FOR AIR IN LINE AND THE MODULE WAS CHANNELED OFF. THE USER THEN IMMEDIATELY CHANNELED OFF AN EPINEPHRINE INFUSION RUNNING ON ANOTHER MODULE. THERE WERE NO OTHER ALARMS PRIOR TO THE DEVICES BEING CHANNELED OFF BY THE USER. THE DEVICE PASSED THE PREVENTIVE MAINTENANCE TESTING. THE ROOT CAUSE OF THE REPORTED EVENT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE CUSTOMER¿S MEDSUN REPORT FROM FDA WHICH STATES: ¿THE PATIENT WAS ON LEVOPHED @ 0.2 MCG/KG/MIN. WITHOUT WARNING, THE ALARIS IV PUMP TURNED OFF AND DISPLAYED A RED WARNING MESSAGE ABOUT AN ERROR ON THE CENTRAL PUMP BRAIN. THE LEVOPHED WAS INFUSING IN A CHANNEL TO THE RIGHT OF THE BRAIN WHICH HAD A SINGLE CHANNEL. THERE WERE TWO OTHER CHANNELS/MEDICATIONS INFUSING TO THE LEFT OF THE BRAIN WHICH WERE REPORTEDLY UNAFFECTED. THE PATIENT'S MEAN ARTERIAL PRESSURE DROPPED INTO THE 50S. THE NURSE WAS ABLE TO TOUCH A BUTTON ON THE PUMP (DOESN'T RECALL WHICH BUTTON) AND THE INFUSION STARTED UP AGAIN WITHOUT THE NURSE DISCONNECTING ANY CHANNELS. REPORTEDLY, THE BLOOD PRESSURE IMPROVED AFTER RESTARTING THE LEVOPHED BUT AT SOME POINT SHORTLY AFTER THAT, THE PATIENT SUFFERED A CARDIAC ARREST AND EXPIRED. BIOMED WAS UNABLE TO TEST THE DEVICE OR RUN ERROR LOGS DUE TO THE WRONG PUMP BEING SEQUESTERED. THE PATIENT WAS CRITICALLY ILL. THE PATIENT DEMONSTRATED EKG CHANGES REFLECTIVE OF A MYOCARDIAL INFARCTION. IT IS UNCLEAR AS OF YET HOW MUCH THE PUMP MALFUNCTION CONTRIBUTED TO THE PATIENT'S DETERIORATION AND ULTIMATE OUTCOME." THE CUSTOMER ALSO REPORTED THE EVENT DIRECTLY TO BD FIELD PERSONNEL DURING A SITE VISIT, AND SUBSEQUENTLY PROVIDED DEVICE LOGS TO THE ON-SITE PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839651 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death (2) 8100, 8015, (4) PRI TUBING