BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 20368914 · Received October 4, 2024

    Report

    Report Number
    1314492-2024-03091
    Event Type
    Death
    Date Received
    October 4, 2024
    Report Date
    February 17, 2025
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION D3: DEVICE MANUFACTURER NAME BAXTER HEALTHCARE CORPORATION. ADDITIONAL INFORMATION D9, H2, H3, H6 AND H11: H11: PER FURTHER COMMUNICATION RECEIVED FROM A BAXTER TERRITORY MANAGER, THE CUSTOMER USED UNAPPROVED CLEANING PRACTICES, INCLUDING CLEANING THE PUMP WITHOUT REMOVING THE BATTERY FROM THE PUMP. THE USER FACILITY HAS SINCE UPDATED THEIR CLEANING PRACTICES WITH ASSISTANCE FROM THE BAXTER TERRITORY MANAGER. POOR CLEANING PRACTICE IS A KNOWN CAUSE OF POWER ISSUES WHEN THE PUMP IS USED ON BATTERY POWER. FA-2020-012 ADDRESSES THE RELATIONSHIP BETWEEN THE POOR CLEANING PRACTICES AND PUMP SHUT DOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H11: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, AN IMPROPER SHUTDOWN COULD NOT BE REPRODUCED, AND NO ISSUES WERE FOUND WITH THE ASSOCIATED WIRELESS BATTERY MODULE CONTACT PINS OR REAR CASE PINS. THE EVENT HISTORY LOG (EHL) REVIEW WAS PERFORMED AND REVEALED A SINGLE EVENT OF "IMPROPER SHUTDOWN!" WHILE RUNNING ON AN INFUSION OF EPINEPHRINE. HOWEVER, AT THE TIME OF THE POWER LOSS, THE PUMP WAS IN STANDBY MODE. THIS MEANS ¿POWER WAS LOST¿ COULD NOT BE DETERMINED THROUGH THE HISTORY LOG. THE USER POWERED ON THE PUMP AT 13:05 ON THE DAY OF THE EVENT AND CLEARED THE PRIOR PROGRAM. THE POWER STATUS RECORDED IN THE HISTORY LOG INDICATED THAT THE PUMP WAS ON BATTERY POWER AT THE TIME. 13:12 USER LOADED A SET, AND A NEW INFUSION OF EPINEPHRINE WAS PROGRAMMED 13:13 THE USER STARTED THE INFUSION AT A RATE OF 281ML/HOUR WITH A VTBI OF 250ML 13:52 THE USER STOPPED THE PUMP AND PUT THE PUMP IN STANDBY MODE. THE PUMP IS NOT RUNNING WHEN IN STANDBY MODE. 14:10 THE USER POWERED ON THE PUMP AND AN "IMPROPER SHUTDOWN!" MESSAGE OCCURRED INDICATING A LOSS OF POWER BETWEEN TIMESTAMPS 13:52 AND 14:10. THE POWER STATUS INDICATED THAT THE PUMP WAS ON BATTERY POWER AT THE TIME OF POWER UP. NO BATTERY ALERTS HAD OCCURRED PRIOR TO THE IMPROPER SHUTDOWN EVENT. AN "IMPROPER SHUTDOWN!" MESSAGE INDICATES THAT ALL POWER WAS LOST FROM THE PUMP. HOWEVER, THE LOG CANNOT BE USED TO DETERMINE IF THE POWER WAS MANUALLY DISCONNECTED OR THE SHUTDOWN WITHOUT USER INPUT. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED A SPECTRUM PUMP STOPPED INFUSING AND "DIED" WITHOUT ALARMING A LOW BATTERY. DURING TRANSPORT FROM THE INTENSIVE CARE UNIT TO COMPUTED TOMOGRAPHY (CT) SCAN, THE PATIENT WAS RECEIVING LACTATED RINGERS (DOSE, PROGRAMMED VOLUME AND DELIVERY RATE UNKNOWN) AND EPINEPHRINE VIA A SECOND SPECTRUM PUMP. WHILE EN ROUTE THE PUMP ¿STOPPED WORKING¿ AND THE STAFF WAS UNAWARE OF THIS STOPPAGE AND ¿IT¿S POSSIBLE (THAT THE) NOTICE WAS GIVEN THAT THE BATTERY WAS FAILING BUT DUE TO THE STRESS OF THE SITUATION SOMEONE COULD HAVE IGNORED THE ALARM¿. AT THIS POINT THE PUMP HAD BEEN IN USE FOR ¿TWO PLUS HOURS¿. AFTER AN UNSPECIFIED AMOUNT OF TIME THE PATIENT DIED. IT WAS NOT REPORTED WHAT WAS THE CAUSE OF DEATH NOR WAS IT REPORTED IF AN AUTOPSY HAD BEEN REQUESTED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403817 SIGMA SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 35700BAX2 NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death 0004F3515DE9 BATTERY| EPINEPHRINE| RINGERS LACTATE| SPECTRUM PUMP (SERIAL #) (B)(6)