BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2299215 · Received October 5, 2011

    Report

    Report Number
    2016493-2011-00516
    Event Type
    Death
    Date Received
    October 5, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 8, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. THE CUSTOMER'S REQUEST FOR A DEVICE AND EVENT LOG INVESTIGATION HAS BEEN COMPLETED. NO DEVICE MALFUNCTION WAS ALLEGED. THE PUMP MODULES AND ASSOCIATED PC UNIT LOGS WERE REVIEWED FOR ANY DEVICE ANOMALIES WHERE PRECEDEX AND PHENYLEPHRINE WERE INFUSING. THE PC UNIT (SERIAL NUMBER = (B)(4)) WAS POWERED ON AT 11:27 AM ON (B)(6) 2011. A FEW SECONDS LATER, PUMP MODULE (SERIAL NUMBER = (B)(4)) WAS ADDED. THE DEVICE WAS SET TO THE ADULT CRITICAL CARE PROFILE. PUMP MODULE (SERIAL NUMBER = (B)(4)) WAS PROGRAMMED USING GUARDRAILS TO INFUSE DEXMEDETOMIDINE (PRECEDEX) (DRUG ID: (B)(4)) WITH A RATE = 22.5ML/HR, VTBI=85ML, AND A CONCENTRATION = 4MCG/ML. A SOFT GUARDRAIL ALERT WAS TRIGGERED BECAUSE THE PROGRAMMED DOSE OF 1MCG/KG/H EXCEEDED THE GUARDRAIL LIMIT OF 0.7MCG/KG/H. THE USER CHOSE TO PROCEED WITH PROGRAMMING, AND STARTED THE INFUSION. AT 11:38 AM, THE USER CHANGED THE DOSE TO 0.6MCG/KG/H WHICH RECALCULATED THE RATE TO RATE = 13.5ML/HR AND STARTED THE INFUSION. AT 12:21 PM, THE USER LOWERED THE DOSE TO 0.4MCG/KG/H WHICH RECALCULATED THE RATE TO 11.25ML/HR AND THE INFUSION STARTED. AT 1:26 PM, THE USER POWERED OFF THE CHANNEL (IDLE) SHOWING A VOLUME INFUSED=24.107ML. AT 12:36 PM, PUMP MODULE (SERIAL NUMBER = (B)(4)) WAS ADDED. AT 12:40 PM, THE PUMP WAS PROGRAMMED AND STARTED USING GUARDRAILS TO INFUSE PHENYLEPHRINE (DRUG ID: (B)(6)) WITH A RATE=5ML/HR, VTBI=200ML, AND A CONCENTRATION=200MCG/ML. AT 12:51 PM, THE USER CHANGED THE RATE TO 10ML/HR. ABOUT 2 MINUTES LATER, THE RATE WAS CHANGED TO 20ML/HR AND THE INFUSION STARTED. A FEW MINUTES LATER AT 1:01 PM, THE USER RAISED THE RATE TO 25ML/HR AND STARTED THE INFUSION. ABOUT A MINUTE LATER AT 1:02 PM, ANOTHER RATE CHANGE OCCURRED WHEN THE USER CHANGED THE RATE TO 20ML/HR. AT ABOUT 1:06 PM, THE RATE WAS CHANGED TO 13.5ML/HR AND THE INFUSION STARTED. AT APPROXIMATELY 1:18 PM, THE RATE WAS RAISED AGAIN TO 25ML/HR AND THE INFUSION STARTED. AT ABOUT 1:22 PM, THE RATE WAS RAISED FOR THE FINAL TIME TO 30ML/HR AND THE INFUSION STARTED. AT 1:32 PM, THE USER POWERED OFF THE CHANNEL (IDLE) SHOWING A VOLUME INFUSED = 16.089ML. THE DEVICE PASSED ALL TESTING. THE TESTS PERFORMED WERE AS FOLLOWS: VISUAL INSPECTION, DISPLAY TESTING, CHANNEL ID/IUI CONNECTOR TEST, ALARM TEST, KEYPAD TEST, DOOR AJAR/SAFETY CLAMP SENSOR TEST, AIR-IN-LINE SENSOR TEST, RATE ACCURACY VERIFICATION, PT SIDE PRESSURE TESTING, FLUID SIDE OCCLUSION TESTING AND X-RAY INSPECTION. THE DEVICE OPERATED ACCORDING TO SPECIFICATION. ROOT CAUSE OF THE CUSTOMER'S REPORTED PROBLEM IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED A DEVICE AND EVENT LOG INVESTIGATION BECAUSE PT EXPIRED UNEXPECTEDLY. THE CUSTOMER DID NOT NOTE ANY ISSUES WITH THE ALARIS SYSTEM AND IS NOT ALLEGING ANY MALFUNCTION, BUT AS PART OF THE INVESTIGATION OF THE DEATH THEY ARE REQUESTING THE DEVICE BE CHECKED FOR ANY ISSUES AND THAT THE EVENT LOGS BE REVIEWED TO DETERMINE EXACTLY WHAT WAS PROGRAMMED. PT WAS BEING PREPPED FOR AN OPERATING ROOM CASE AROUND 11:40AM. ONE MODULE WAS INFUSING PRECEDEX SEDATIVE AT TITRATED RATES (CONCENTRATION AND RATES NOT AVAILABLE). REPORTER DOES NOT KNOW WHAT WAS INFUSING ON THE SECOND CHANNEL. THE PT HAD A CARDIAC ARREST AROUND 2:15 PM BEFORE ANY SURGERY WAS STARTED. CUSTOMER STATED SHE DID NOT WISH TO SHARE ANY FURTHER DETAILS ABOUT THE PT OR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death MODEL/LOT # UNK| ALARIS PUMP MODULE ADMINISTRATION SET,| ALARIS PC UNIT, SN (B)(4)| ALARIS PUMP MODULE, SN (B)(4)