BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS® PCA MODULE

    MDR report key: 7997127 · Received October 23, 2018

    Report

    Report Number
    2016493-2018-00766
    Event Type
    Death
    Date Received
    October 23, 2018
    Date of Event
    September 14, 2018
    Report Date
    September 21, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (4)8100; PCA TUBING; (4)PRI TUBING; (3)8015; 60 ML MONOJECT SYRINGE; 30 ML BD SYRINGE; EVENT DATE (B)(6) 2018. THE CUSTOMER¿S REPORT OF MISSING/UNRECOVERABLE DATA WAS NOT CONFIRMED. REVIEW OF THE LOGS SHOWED NO DATA WAS MISSING FOR THE REPORTED TIME FRAME OF 12:23 PM TO 2:48 PM ON (B)(6) 2018. THE LOG SHOWS THAT THE PCA MODULE WAS PREVIOUSLY PROGRAMMED TO INFUSE A PCA DOSE + CONTINUOUS INFUSION OF HYDROMORPHONE 50MG/25ML WITH A CONTINUOUS RATE OF 0.5ML/HR AND EACH PCA DOSE DELIVERING 0.25ML. AT 10:59 AM ON (B)(6) 2018 THE USER PROGRAMMED A DIFFERENT CONCENTRATION OF HYDROMORPHONE 5MG/25ML (0.2MG/ML) WITH A CONTINUOUS RATE OF 5ML/HR AND EACH PCA DOSE REQUEST TO DELIVER 2.5ML. AT 11:50 AM THE SYRINGE WAS EMPTY. THE DEVICE WAS CHANNELED OFF AND IN THE IDLE STATE. AT 12:13 PM THE USER SELECTED THE PCA MODULE AND THEN SELECTED A 30ML BD SYRINGE WITH 24.3741ML DETECTED. AT 12:15 PM, THE USER RESTORED THE PREVIOUS PCA DOSE + CONTINUOUS INFUSION OF HYDROMORPHONE 5MG/25ML AND STARTED THE INFUSION. THE INFUSION CONTINUED UNTIL 2:48 PM WHEN THE DEVICE WAS CHANNELED OFF, WITH 12.7212ML RECORDED AS BEING DELIVERED DURING THIS PERIOD. THE REASON FOR THE GAP IN TIME, OR LACK OF ENTRIES IN THE LOG, IS THE FACT THAT THERE WERE NO EVENTS TO RECORD DURING THIS PERIOD. ITEMS ARE ONLY RECORDED IN THE LOG WHEN ¿EVENTS¿ OCCUR, SUCH AS KEY PRESSES, DOSE REQUESTS, ALARMS, ETC. THE ROOT CAUSE OF THE REPORT OF MISSING/UNRECOVERABLE DATA WAS A MISUNDERSTANDING OF HOW DEVICE LOGS RECORD DATA. DURING THE TIME PERIOD OF INTEREST THE DEVICE WAS RUNNING A CONTINUOUS INFUSION WITH NO OTHER EVENTS THEREFORE NO INFORMATION WAS LOGGED. DEVICES NOT RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PALLIATIVE CARE PATIENT WITH AN OBSTRUCTED TRACHEOSTOMY DUE TO A CANCEROUS MASS WAS RECEIVING A CONTINUOUS DOSE OF DILAUDID AT 1MG/HOUR WITH A PATIENT CONTROLLED ANALGESIA DEMAND DOSE OF 0.25MG EVERY 15 MINUTES. AT APPROXIMATELY 11:30 TO 12:30, THE NURSE CHANGED THE PCA SYRINGE AND REPORTEDLY PROGRAMMED THE INFUSION "INCORRECTLY" WHICH SUBSEQUENTLY LED THE PATIENT TO PULL OUT THE IV AND TRACHEOSTOMY AND PASS AWAY. DURING THE CUSTOMER'S INTERNAL INVESTIGATION, PHARMACY IDENTIFIED THAT DILAUDID 15MG WAS MISSING, BEGAN TO REVIEW THE EVENT LOGS FOR THE TIMEFRAME OF 12:48-14:43, AND FOUND THAT THERE WAS MISSING AND UNRECOVERABLE DATA THAT IS VERY IMPORTANT REGARDING THEIR INTERNAL INVESTIGATION OF THE MISSING CONTROLLED SUBSTANCE. DUE TO THIS EVENT, THE CUSTOMER CONTINUED THEIR INVESTIGATION FURTHER AND FOUND THAT TWO OTHER FACILITIES WITHIN THEIR HEALTH SYSTEM WERE ALSO EXPERIENCING MISSING AND UNRECOVERABLE DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835846 ALARIS® PCA MODULE PUMP, INFUSION FRN CAREFUSION 8120

    Patients

    Seq Age Sex Outcome Treatment
    1 Death