BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 6177460 · Received December 15, 2016

    Report

    Report Number
    2016493-2016-00950
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    October 10, 2016
    Report Date
    November 1, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A PUMP SHUT DOWN WAS CONFIRMED IN THE PCU EVENT LOG. THE LOG SHOWS THAT AT 12:25 AM ON (B)(6) 2016 PUMP MODULE S/N (B)(4) WAS PROGRAMMED TO INFUSE VASOPRESSIN PRESSOR 50 UNIT/250ML AT 9ML/HR. THE DEVICE WAS THEN PROGRAMMED FOR A DELAY FOR 120 MINUTES. AT 1:37 AM, THE DEVICE MALFUNCTIONED WHICH CAUSED THE INFUSION TO STOP. THE PCU ERROR LOG AND THE PUMP MODULE ERROR LOG BOTH SHOW THAT THE MALFUNCTION SEEN IN THE PCU EVENT LOG WERE FOR ERROR CODE 241.4140.0, LOWER PRESSURE SENSOR FAILURE. AFTER THE MALFUNCTION OCCURRED, CHANNEL D, PUMP MODULE S/N (B)(4) WHICH WAS INFUSING AT 42ML/HR WAS REMOVED; THE CONFIRM SOFTKEY WAS SELECTED IN RESPONSE TO THE CHANNEL DISCONNECT POP-UP. CHANNEL D WAS THEN RE-ADDED TO THE SYSTEM. HOWEVER, BECAUSE THE PRIOR CHANNEL ERROR HAD NOT BEEN CONFIRMED THE PCU STILL DISPLAYED THE RED CHANNEL ERROR SCREEN. BOTH CHANNELS C AND UNIT D WERE THEN DISCONNECTED FROM THE SYSTEM, WHICH CLEARED THE RED SCREEN FROM THE PCU. THE CHANNELS WERE THEN RE-ADDED TO THE SYSTEM AND THEN SUBSEQUENTLY REMOVED. NEITHER PUMP MODULE WAS REPROGRAMMED BEFORE BEING REMOVED FROM THE SYSTEM. THE ERROR WAS NOT REPLICATED DURING FUNCTIONAL TESTING; HOWEVER, THE LOWER SENSOR WAS OBSERVED TO BE SLIGHTLY OUT OF RANGE AND COULD BE THE REASON FOR THE INTERMITTENT FAILURES. THE CAUSE OF THE PUMP SHUT DOWN WAS A PUMP MALFUNCTION (SENSOR BROKEN LOW ¿ ERROR CODE 241.4140.0). THE ROOT CAUSE OF THE MALFUNCTION WAS NOT IDENTIFIED. THE ERROR WAS NOT REPLICATED DURING FUNCTIONAL TESTING. IT CANNOT BE DETERMINED IF THE CHANNEL DISCONNECTS WERE REMOVALS OR IF THE DISCONNECTS WERE DUE TO THE USER TRYING TO ADDRESS THE RED SCREEN ALARM DISPLAYED ON THE PCU DUE TO THE CHANNEL MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS HEMODYNAMICALLY UNSTABLE AND RECEIVING 3 VASOPRESSOR INFUSIONS INCLUDING HIGH DOSE EPINEPHRINE AND LEVOPHED. THE IV PUMP WAS PLUGGED INTO THE WALL. CHANNEL C WITH EPINEPHRINE AT 0.05 MCG/KG/MIN ALARMED FOR A ¿CHANNEL DISCONNECT¿ AND SHUT DOWN. THE CHANNEL WAS COULD NOT BE RESTARTED AND THE EPINEPHRINE DRIP WAS SWITCHED TO ANOTHER PUMP. DURING THE TRANSITION TIME, THE PATIENT¿S BLOOD PRESSURE DROPPED AND 0.2MG OF EPINEPHRINE WAS GIVEN IV PUSH. AFTER RESTORING THE EPINEPHRINE ONTO A NEW PUMP, THE PATIENT¿S BLOOD PRESSURE BRIEFLY RETURNED TO BASELINE, HOWEVER A SHORT TIME LATER, IT DROPPED AGAIN AND THE PATIENT WENT INTO CARDIAC ARREST. RESUSCITATION WAS INITIALLY SUCCESSFUL BUT THE PATIENT SUFFERED A SECOND ARREST AND THE FAMILY OPTED TO STOP RESUSCITATION EFFORTS; THE PATIENT THEN EXPIRED. A SECOND CHANNEL ON THE SYSTEM, DELIVERING VASOPRESSIN, WAS ALSO REPORTED TO HAVE FAILED IN AN UNSPECIFIED MANNER DURING THE RESUSCITATIVE EFFORTS BUT THIS FAILURE WAS NOT THOUGHT TO HAVE A SIGNIFICANT IMPACT ON THE PATIENT AND THE CHANNEL WAS QUICKLY RESTARTED. RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM FDA WHICH STATES: "EVENT DESC: PATIENT WAS IN CRITICAL CONDITION WITH 3 VASOPRESSOR MEDICATIONS INFUSING VIA THE ALARIS PUMP. ONE OF THE PUMP CHANNELS INFUSING EPINEPHRINE SUDDENLY BEEPED AND SAID "CHANNEL DISCONNECT" AND SHUT DOWN. THE BEDSIDE NURSE WAS UNABLE TO GET THE CHANNEL TO WORK AGAIN. THE MEDICATION WAS SWITCHED TO ANOTHER ALARIS IV PUMP AND EPINEPHRINE WAS RESTORED TO THE PATIENT. IN THE TIME PERIOD THAT IT TOOK FOR THE EPINEPHRINE TO BE RESTARTED, THE PATIENT'S BLOOD PRESSURE DROPPED PRECIPITOUSLY. BLOOD PRESSURE WAS RESTORED AFTER 2 IV PUSHES OF EPINEPHRINE AND THE DRIP BEING RESTARTED. SEVERAL MINUTES LATER, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND SHE SUFFERED A CARDIAC ARREST. THE PATIENT REGAINED SPONTANEOUS CIRCULATION AFTER SEVERAL MINUTES OF CPR BUT THEN FAMILY THEN OPTED FOR DNR STATUS WITH NO ESCALATION OF CARE AND THE PATIENT ULTIMATELY EXPIRED. THE ATTENDING PHYSICIAN FEELS THAT THE PATIENT'S UNDERLYING CONDITION WAS THE CAUSE OF HER DEATH BUT ALSO THINKS THE PUMP MALFUNCTION MADE SOME CONTRIBUTION TO HER DETERIORATION. BIOMED TESTING: WE RECEIVED THIS PUMP THIS MORNING TAGGED FOR AN INCIDENT. THE PROBLEM DESCRIPTION IS "CHANNEL ERROR WHILE INFUSING DRUG, CHANNEL THEN SHUT DOWN." THIS IS ANOTHER CHECK IV SET ERROR CAUSED BY A BAD BOTTLE SIDE PRESSURE SENSOR VOLTAGE. THE ERROR LOG SHOWS MULTIPLE INSTANCES OF THIS ERROR (AT FATAL SEVERITY) THROUGHOUT THE MONTH. BASED ON THE RECORDS IN TMS, THIS PUMP HAS THE ORIGINAL PRESSURE SENSOR FROM THE FACTORY. THIS IS THE THIRD ERROR RELATED TO PRESSURE SENSOR FAILURES THAT WE HAVE HAD IN A WEEK. THIS IS ALSO NOT THE FIRST PUMP WITH THESE ERRORS THAT WE HAVE NOT GOTTEN NOTIFIED ABOUT AFTER THE INITIAL MALFUNCTION. THE IV PUMP IN QUESTION HAD BEEN PLUGGED INTO A WALL OUTLET WHEN THE EVENT OCCURRED. BIOMED DEPT LATER TESTED THE WALL OUTLETS AND FOUND NO ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828150 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death 8015,(3) 8100,(2)PRI TUBING