BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6109592 · Received November 17, 2016

    Report

    Report Number
    2016493-2016-00831
    Event Type
    Death
    Date Received
    November 17, 2016
    Date of Event
    August 18, 2016
    Report Date
    September 28, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: 8600, THERAPY DATE: (B)(6) 2016. THE CUSTOMER'S REPORT THAT THE PUMP STOPPED WORKING WAS CONFIRMED. PHYSICAL INSPECTION NOTED THE DEVICE TO BE IN FAIR CONDITION WITH THE INSTRUMENT SEAL NOT INTACT. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT FOUR MODULES WERE ATTACHED AND IN USE AT THE TIME OF THE EVENT. ON (B)(6) 2016 BETWEEN 1:06 PM AND 1:07 PM, THE TAMPER SWITCH WAS PUSHED SEVERAL TIMES WHICH LOCKED AND UNLOCKED THE FRONT PANEL. THE LAST PUSH AT 1:07 PM LOCKED THE FRONT PANEL. SUBSEQUENTLY, 2 OF THE 4 INFUSIONS ALARMED FOR PATIENT SIDE OCCLUSION AND MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RESOLVE THE ISSUE. DURING THIS TIME THE DOOR OF AN INFUSING PUMP WAS OPENED WHICH CAUSED IT TO ALSO ALARM. AT 1:37 PM, THE TAMPER SWITCH WAS AGAIN ACCESSED WHICH UNLOCKED THE FRONT PANEL. EACH OF THE DEVICES WERE THEN ABLE TO BE TURNED OFF AND THE SYSTEM WAS POWERED OFF. THE DEVICE PASSED TESTING OF THE KEYPAD AND TAMPER SWITCH; NO ISSUES WERE NOTED WITH THE TAMPER SWITCH OR THE SWITCH'S RUBBER SHROUD. THE ROOT CAUSE OF THE CUSTOMER'S REPORT THAT THE PUMP STOPPED WORKING DURING TRANSPORT WAS IDENTIFIED AS A USER ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT WAS UNSTABLE PRIOR TO TRANSPORT FOR A CT SCAN, AND NOT EXPECTED TO SURVIVE. MEDICATIONS INFUSING WERE NOREPINEPHRINE, A VASOPRESSOR, AND TWO OTHER UNNAMED DRUGS. DURING TRANSPORT 3 CHANNELS RANG OCCLUDED AT THE SAME TIME, HOWEVER NOTHING WAS WORKING ON THE DEVICES. THE IV ACCESS WAS DETERMINED TO BE PATENT; UNSPECIFIED RESCUE MEDICATION WAS GIVEN IV PUSH AND INFUSIONS WERE CONTINUED VIA GRAVITY. THE PATIENT WAS TRANSPORTED BACK TO THE CRITICAL CARE UNIT AND EXPIRED UPON ARRIVAL. THE MESSAGE DISPLAYED ON THE PCU AT THE TIME OF THE EVENT IS NOT KNOWN, HOWEVER IT WAS THEORIZED BY ANOTHER STAFF MEMBER THAT THE DEVICE WAS LOCKED. NO OTHER EVENT DETAILS WERE PROVIDED. THE DISPOSABLE SETS WERE NOT SAVED, BUT THE DEVICES WERE SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762367 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4), (4)PRI TUBING, TD: (B)(6) 2016