BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 9629457 · Received January 24, 2020

    Report

    Report Number
    2016493-2020-00104
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    November 28, 2019
    Report Date
    December 31, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE THAT THE SYSTEM HAD ALARMED WITH A RED SCREEN WHILE FOUR ACTIVE INFUSIONS WERE RUNNING WAS CONFIRMED VIA LOG ANALYSIS. THE INSPECTION PROCESS DID NOT FIND ANY ISSUES THAT WOULD HAVE POTENTIALLY BEEN A CONTRIBUTING FACTOR . THE SYSTEM HAD BEEN PLACED IN OPERATION WITH THE AC POWER DISCONNECTED WHICH HAD THE SYSTEM RUNNING ON MAIN BATTERY POWER. A LOW BATTERY ALARM WAS GENERATED 2 HOURS LATER; HOWEVER HAD A ¿BATTERY DISCHARGED¿ ALARM OCCUR WITHIN THREE SECONDS AFTER THE LOW BATTERY ALARM WITH NO PRIOR VERY LOW BATTERY ALARM. THE BATTERY LOG COVERED A PERIOD OF 540 DAYS AND WAS FOUND VOID OF ANY RECORDED BATTERY CONDITIONING, WHICH SHOULD BE PERFORMED ANNUALLY TO ENSURE PROPER BATTERY OPERATION. AFTER BATTERY CONDITIONING AND TESTING RESULTED IN THE BATTERY APPROPRIATELY ALARMING THROUGH ALL PHASES OF LOW BATTERY DETECTION WHILE IN OPERATION UNDER THE SAME INFUSION PARAMETERS AS THE INCIDENT. THE AC POWER WAS NOTED WITHIN THE BATTERY LOG TO HAVE QUITE A FEW EVENTS OF THE AC POWER TOGGLING ON AND OFF; THIS WAS NOT SEEN DURING THE INVESTIGATION. IT IS RECOMMENDED THE CUSTOMER HAVE AN EXPERIENCED PERSON EVALUATE THE INTEGRITY OF THE AC POWER SOURCES BEING UTILIZED. THE LB2 (LESS THAN FIVE MINUTES REMAINING) LOW BATTERY ALARM WAS MISSED WAS ATTRIBUTED TO THE BATTERY CAPACITY BEING INADEQUATE FOR THE LOAD IT WAS UNDER. A FULLY CHARGED BATTERY WITH IT AT FULL CAPACITY WILL PROVIDE ADEQUATE TIME SEPARATION BETWEEN ALARMS; HOWEVER THIS TIME WILL DECREASE AS BATTERY CAPACITY DECREASES. FUNCTIONAL TESTING SHOWED NO ANOMALIES. THE ROOT CAUSE OF THE REPORT THAT THE PUMP SHUTDOWN WHILE VASOPRESSORS INFUSING IS BEING ATTRIBUTED TO AN INADEQUATELY CHARGED BATTERY IN COMBINATION WITH NOT HAVING HAD PERFORMED ANNUAL BATTERY MAINTENANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PUMP RUNNING INFUSIONS OF NOREPINEPHRINE[LEVOPHED], AMIODARONE, PHENYLEPHRINE [VAZCULEP], AND MILRINONE MADE A LOUD NOISE AND POWERED OFF. AFTER THE ALARM SOUNDED THE PUMP WENT RED AND READ SYSTEM ERROR. NEXT, THE PUMP GAVE THE OPTION TO TURN IT OFF, HOWEVER BEFORE THE NURSE COULD POWER OFF THE PUMP IT COMPLETELY SHUT DOWN. THE PATIENT IMMEDIATELY BECAME HYPOTENSIVE. THE NURSE PRACTITIONER INTERVENED AND GAVE AN ORDER FOR PHENYLEPHRINE 200MG IV PUSH FOR THE PATIENT. THE NURSE REALIZED THE PUMPS WERE NOT PLUGGED INTO THE POWER BAR ON THE IV POLE. THE PUMPS WERE TURNED ON AGAIN AND RESTORED WITHIN A FEW MINUTES THE PUMPS GAVE NO WARNING THEY HAD A LOW BATTERY OR NEEDED TO BE PLUGGED IN. THIS EVENT OCCURRED ON THE INTENSIVE CARE UNIT (ICU). RECEIVED A COPY OF THE CUSTOMER'S CMDSNET PROGRAM REPORT FROM HEALTH CANADA WHICH STATES, ¿NURSE WENT IN TO TITRATE NOREPINEPHRINE AND ONCE SAME COMPLETED, THE IV PUMP WITH NOREPINEPHRINE, AMIODARONE, PHENYLEPHRINE, MILRINONE RUNNING THROUGH MADE A LOUD ALARM NOISE AND WENT RED AND SAID SYSTEM ERROR, THEN ONLY GAVE NURSE THE OPTION TO TURN IT OFF, NURSE DIDN'T BECAUSE BUT WITHIN A MOMENT THE PUMP COMPLETELY SHUT DOWN, NURSE QUICKLY YELLED FOR HELP AND A NEW PUMP, THEN PLUGGED POWER BAR INTO THE WALL BUT DIDN'T NOTICE AT THAT MOMENT THAT THE PUMPS WERE NOT PLUGGED INTO THE POWER BAR ON THE IV POLE. THE NURSE PRACTITIONER ON GAVE AN ORDER FOR PHENYLEPHRINE 200MG IV PUSH, THEN THE PUMPS WERE TURNED ON AGAIN AND RESTORED WITHIN A FEW MINUTES. THE PUMPS GAVE NO WARNING OF LOW BATTERY OR NEEDING TO BE PLUGGED IN THEY JUST GAVE SYSTEM ERRORED AND SHUT DOWN."

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP RUNNING INFUSIONS OF NOREPINEPHRINE[LEVOPHED], AMIODARONE, PHENYLEPHRINE [VAZCULEP], AND MILRINONE MADE A LOUD NOISE AND POWERED OFF. AFTER THE ALARM SOUNDED THE PUMP WENT RED AND READ SYSTEM ERROR. NEXT, THE PUMP GAVE THE OPTION TO TURN IT OFF, HOWEVER BEFORE THE NURSE COULD POWER OFF THE PUMP IT COMPLETELY SHUT DOWN. THE PATIENT IMMEDIATELY BECAME HYPOTENSIVE. THE NURSE PRACTITIONER INTERVENED AND GAVE AN ORDER FOR PHENYLEPHRINE 200MG IV PUSH FOR THE PATIENT. THE NURSE REALIZED THE PUMPS WERE NOT PLUGGED INTO THE POWER BAR ON THE IV POLE. THE PUMPS WERE TURNED ON AGAIN AND RESTORED WITHIN A FEW MINUTES THE PUMPS GAVE NO WARNING THEY HAD A LOW BATTERY OR NEEDED TO BE PLUGGED IN. THIS EVENT OCCURRED IN THE INTENSIVE CARE UNIT (ICU). RECEIVED A COPY OF THE CUSTOMER'S (B)(6) REPORT FROM (B)(6) WHICH STATES, ¿NURSE WENT IN TO TITRATE NOREPINEPHRINE AND ONCE SAME COMPLETED, THE IV PUMP WITH NOREPINEPHRINE, AMIODARONE, PHENYLEPHRINE, MILRINONE RUNNING THROUGH MADE A LOUD ALARM NOISE AND WENT RED AND SAID SYSTEM ERROR, THEN ONLY GAVE NURSE THE OPTION TO TURN IT OFF, NURSE DIDN'T BECAUSE BUT WITHIN A MOMENT THE PUMP COMPLETELY SHUT DOWN, NURSE QUICKLY YELLED FOR HELP AND A NEW PUMP, THEN PLUGGED POWER BAR INTO THE WALL BUT DIDN'T NOTICE AT THAT MOMENT THAT THE PUMPS WERE NOT PLUGGED INTO THE POWER BAR ON THE IV POLE. THE NURSE PRACTITIONER ON GAVE AN ORDER FOR PHENYLEPHRINE 200MG IV PUSH, THEN THE PUMPS WERE TURNED ON AGAIN AND RESTORED WITHIN A FEW MINUTES. THE PUMPS GAVE NO WARNING OF LOW BATTERY OR NEEDING TO BE PLUGGED IN THEY JUST GAVE SYSTEM ERRORED AND SHUT DOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88818 ALARIS PC UNIT PUMP,INFUSION FRN CAREFUSION 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (4)8100, (4)PRI TUBING, 8600, TD (B)(6) 2019