BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 11325611 · Received February 12, 2021

    Report

    Report Number
    2016493-2021-25580
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    February 2, 2021
    Report Date
    February 3, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZE: THE CUSTOMER REPORTED EVENT THAT THE DEVICE ALARMED ¿NETWORK CONNECTION RESET¿ DURING CONTINUOUS INFUSIONS WAS CONFIRMED DURING LOG REVIEW BUT COULD NOT BE REPRODUCED DURING TESTING. THE REPORTED ISSUE THAT MEDICATIONS INFUSING WERE BRIEFLY PAUSED WHEN DEVICE ALARMED WAS NOT CONFIRMED OR REPLICATED. THE ERROR LOG SHOWS THAT ON 02/02/2021: CODE 800.8000.0 OCCURRED AT 08:33:50 AM. CODE 600.6920.5 (CIB_REBOOTED) OCCURRED AT 08:34:04 AM, AND CODE 600.6850.5 (CIB_DEVICE_NOT_RESPONDING) OCCURRED AT 08:34:34 AM. THE EVENT LOG SHOWS THAT AT 08:34:34 AM, CIB RELATED ERRORS OCCURRED WHILE THREE DEVICES WERE INFUSING DRUGS. THE USER SELECTS SOFT KEY 13 (CONFIRM) TO THE NETWORK CONNECTION ERROR AT 08:54:04 AM. THE USER REPROGRAMMED THE DOSE FOR THE EPINEPHRINE INFUSION AT 08:56:27 AM TO 0.07 MCG/KG/MIN WITH THE RATE CHANGED TO 2.1 ML/H WITH THE VTBI OF 14.6613 ML. INFUSION CONTINUED. THE USER REPROGRAMMED THE DOSE FOR THE MILRINONE INFUSION AT 09:02 AM TO 0.75 MCG/KG/MIN WITH THE CHANGED RATE TO 1.13 ML/H WITH THE VTBI OF 31.5698 ML. INFUSION CONTINUED. SOFTWARE ENGINEERING EXPLAINED THAT BASED ON THIS ERROR WHICH SHOWED AN OS FAULT (800.8000.0) IN THE PROCESS ¿IPCOM_TICKD¿, THIS FOOTPRINT WAS A MATCH FOR TRACKER 15615. THIS ISSUE LEADS TO A LOSS OF NETWORK CONNECTION. HOWEVER, IT DOES NOT LEAD TO AN INTERRUPTION OF AN INFUSION. CIB IS RESPONSIBLE FOR NETWORK CONNECTION. ALTHOUGH THE CIB WAS GOING DOWN, THE PCU CAN FUNCTION LARGELY WITHOUT THE CIB. PREVIOUS INVESTIGATIONS SHOW THAT THIS FAILURE OF NETWORKING FUNCTIONALITY APPEARS TO BE LINKED TO THE PCU¿S BEHAVIOR WITH RESPECT TO THE DHCP SERVER DEPLOYED AT THE HOSPITAL. THE DHCP SERVER OF THE HOSPITAL NETWORK ASSIGNS THE INITIAL IP ADDRESS LEASE OF 30 MINUTES. WHEN A DCHP LEASE EXPIRES, THE PCU CONTINUES TO USE THE ASSIGNED IP ADDRESS. THE DHCP CLIENT OF THE PCU CONTINUES TO REQUEST THE DHCP LEASE AS EXPECTED, BUT THE DHCP RESPONSE MESSAGES ARE DISCARDED. THIS PROCESS CONTINUES AS LONG AS THE PCU IS CONNECTED TO THE WIRELESS NETWORK. (A DISCONNECTION FROM THE NETWORK WILL RESET THE DHCP CLIENT AND RESTORE ITS ORIGINAL/PROPER BEHAVIOR). IT IS SUSPECTED THAT AT THIS HOSPITAL THE PCU STAYS IN THE ABOVE-MENTIONED STATE FOR LONG DURATIONS, WHERE IT CONTINUES TO REQUEST IP LEASE BUT IGNORES RESPONSES FROM DHCP SERVER. LABORATORY TESTING PERFORMED DID NOT REPRODUCE THE NETWORK CONNECTION ERRORS. INTERNAL INSPECTION FOUND NO IRREGULARITIES. THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED ISSUE THAT THE DEVICE ALARMED ¿NETWORK CONNECTION RESET¿ DURING CONTINUOUS INFUSIONS IS BELIEVED TO BE AN INTERRUPTION RELATED TO A SOFTWARE LIMITATION THAT PREVENTS THE PCU FROM ACCEPTING ANY UPDATES TO IP LEASE DURATION AFTER THE INITIAL DHCP HANDSHAKE. THE ROOT CAUSE FOR THE REPORTED ISSUE THAT MEDICATIONS INFUSING WERE BRIEFLY PAUSED WHEN THE DEVICE ALARMED COULD NOT BE IDENTIFIED IN THIS INVESTIGATION. THIS ISSUE LEADS TO A LOSS OF NETWORK CONNECTION. HOWEVER, IT DOES NOT LEAD TO AN INTERRUPTION OF AN INFUSION. SAMPLE INSPECTION: THE INSPECTION PROCESS PERFORMED ON PCU SN (B)(6) FOUND NO ISSUES WERE FOUND THAT WERE RELEVANT TO THE REPORTED INCIDENT. THE DAMAGED ISOLATION RIBS AND DRIED RESIDUE ON THE PINS OF THE RIGHT IUI CONNECTOR AND CORROSION ON THE PINS OF THE LEFT IUI CONNECTORS WERE NOT RELEVANT TO THE REPORTED INCIDENT. LOG ANALYSIS RESULTS: THE ERROR LOG SHOWED THAT CODE 800.8000.0 (PCU15 GENERAL OS FAILURE) OCCURRED ON (B)(6) 2021 AT 08:33:50 AM. THE ERROR ODE 600.6920.5 (CIB_REBOOTED) OCCURRED ON (B)(6) 2021 OCCURRED AT 08:34:04 AM. ALSO, ERROR CODE 600.6850.5 (CIB_DEVICE_NOT_RESPONDING) OCCURRED AT 08:34:34 AM. THE EVENT LOG SHOWED THAT ON (B)(6) 2021 AT 08:15:56 AM, SYRINGE MODULE SN (B)(6) WAS SELECTED AND THE USER REPROGRAMMED THE DOSE FOR THE EPINEPHRINE INFUSION TO 0.06 MCG/KG/MIN WHICH AUTOMATICALLY ENTERED THE RATE TO 1.8 ML/H WITH THE VTBI (VOLUME TO BE INFUSED) OF 15.8662 ML. THE INFUSION CONTINUED. 08:34:34 AM, ¿COMM_IF_BOARD_ERROR¿ AND A ¿CIB ERROR¿ OCCURRED. 08:54:04 AM, THE USER SELECTS SOFT KEY 13 (CONFIRM) ON THE PCU. 08:56:27 AM, THE USER SELECTS PUMP MODULE SN (B)(6) AND REPROGRAMMED THE DOSE FOR THE EPINEPHRINE INFUSION TO 0.07 MCG/KG/MIN WITH THE RATE CHANGED TO INFUSE AT 2.1 ML/H WITH THE VTBI OF 14.6613 ML. THE INFUSION CONTINUED AND THE CALCULATED DURATION OF THIS INFUSION IS 6 HOURS 57 MINS. 09:02:09 AM, THE USER SELECTS SYRINGE MODULE SN (B)(6) AND REPROGRAMMED THE DOSE FOR THE MILRINONE INFUSION TO 0.75 MCG/KG/MIN WHICH AUTOMATICALLY ENTERED THE RATE TO 1.13 ML/H WITH THE VTBI OF 31.5698 ML. THE INFUSION CONTINUED AND THE CALCULATED DURATION OF THIS INFUSION IS 27 HOURS 57 MINS. 09:03:00 AM- 02:26:00 PM, THE EVENT LOG SHOWED THAT ALL PROGRAMMED INFUSIONS CONTINUED WITH NO FURTHER CIB RELATED ERRORS OCCURRING. 02:28:45 PM, ALL DEVICES WERE CHANNELED OFF AND PCU SN (B)(6) WAS POWERED DOWN. SOFTWARE ENGINEERING EXPLAINED THAT BASED ON THE ERROR LOG, WHICH SHOWED AN OS FAULT (800.8000.0) IN THE PROCESS ¿IPCOM_TCKD¿ ON (B)(6) 2021 AT 08:33:50 AM, THE FOOTPRINT IS A MATCH FOR TRACKER 15615. THIS ISSUE LEADS TO A LOSS OF NETWORK CONNECTION. HOWEVER, IT DOES NOT LEAD TO AN INTERRUPTION OF AN INFUSION. ALTHOUGH THAT THE CIB WAS GOING DOWN, THE PCU CAN FUNCTION LARGELY WITHOUT CIB. CIB IS RESPONSIBLE FOR THE NETWORK CONNECTION. TEST RESULTS: LABORATORY TESTING PERFORMED DID NOT REPRODUCE THE 800.8000.0 OR CIB RELATED ERRORS. THE CUSTOMER NETWORK CONFIGURATION WAS DELETED FROM THE RETURNED PCU. THE PCU ACCEPTED THE CAD NETWORK CONFIGURATION PACKAGE AND COMMUNICATED WITH THE IN-HOUSE SERVER SUCCESSFULLY. TEST INFUSIONS WERE PROGRAMMED TO INFUSE OVERNIGHT. THE OVERNIGHT TEST INFUSIONS DID NOT REPRODUCE THE NETWORK CONNECTION OR CIB RELATED ERRORS SEEN DURING LOG REVIEW. REMOVING THE WIRELESS NETWORK CARD FROM THE BACK OF THE PCU SHOWED THAT THE DEVICE WAS DISCONNECTED FROM THE IN-HOUSE SERVER AND THE WIRELESS NETWORK, BUT THE PROGRAMMED INFUSIONS WERE NOT INTERRUPTED, WITH NO NETWORK CONNECTION ERRORS REPORTED DISPLAYING ON THE PCU SCREEN. TEST METHODS: NA DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 07/27/2010. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE WAS PERFORMED FOR SN (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CONTINUOUS INFUSION OF EPINEPHRINE WITH AN INTENDED RATE OF 0.1MCG/KG/MIN, 3 ML/HR AND MILRINONE WITH AN INTENDED RATE OF 0.75MCG/KG/MIN, 1.13 ML/HR THE DEVICE ALARMED "NETWORK CONNECTION RESET, CONTINUE MANUALLY Y/N" WHICH BRIEFLY PAUSED BOTH MEDICATIONS. THE NURSE SELECTED "YES" TO CONTINUE MANUALLY AND THE INFUSIONS CONTINUED AS PROGRAMMED. SINCE THE PATIENT WAS UNSTABLE AT THE TIME OF THE EVENT, THE PUMP WAS NOT TAKEN OUT OF SERVICE UNTIL LATER. UPON REVIEW OF THE EVENT LOGS, THE FOLLOWING ERRORS WERE FOUND: 800.8000, 600.6920.5 AND 600.6850.5. THE EVENT OCCURRED IN THE PEDIATRIC INTENSIVE CARE UNIT (PICU). THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. RACE AND ETHNICITY: AFRICAN AMERICAN. ADMITTING DIAGNOSIS: TETROLOGY OF FALLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CONTINUOUS INFUSION OF EPINEPHRINE WITH AN INTENDED RATE OF 0.1MCG/KG/MIN, 3 ML/HR AND MILRINONE WITH AN INTENDED RATE OF 0.75MCG/KG/MIN, 1.13 ML/HR THE DEVICE ALARMED "NETWORK CONNECTION RESET, CONTINUE MANUALLY Y/N" WHICH BRIEFLY PAUSED BOTH MEDICATIONS. THE NURSE SELECTED "YES" TO CONTINUE MANUALLY AND THE INFUSIONS CONTINUED AS PROGRAMMED. SINCE THE PATIENT WAS UNSTABLE AT THE TIME OF THE EVENT, THE PUMP WAS NOT TAKEN OUT OF SERVICE UNTIL LATER. UPON REVIEW OF THE EVENT LOGS, THE FOLLOWING ERRORS WERE FOUND: 800.8000, 600.6920.5 AND 600.6850.5. THE EVENT OCCURRED IN THE PEDIATRIC INTENSIVE CARE UNIT (PICU). THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218940 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO PRI TUBING, TD (B)(6) 2021