BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS POINT OF CARE UNIT

    MDR report key: 2185463 · Received July 20, 2011

    Report

    Report Number
    2016493-2011-00431
    Event Type
    Death
    Date Received
    July 20, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2011. (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN EVALUATED.

    Description of Event or Problem · 1

    BIOMED REPORTED THAT A DEVICE ALARMED FOR LOW BATTERY AND ALL 4 MODULES ATTACHED PAUSED AND WERE NOT INFUSING. THE DEVICE WAS PLUGGED INTO AN AC OUTLET, HOWEVER, IT CONTINUED TO ALARM. THE USERS TRIED PUSHING THE PLUG INTO THE BACK OF THE DEVICE WHICH DID NOT HELP. THE PLUG SHIELD WAS IN PLACE. WHEN THE DEVICE SHUT DOWN, THEY DO NOT RECALL THE PUMP SOUNDING ANY OF THE USUAL ALERTS WHEN THE BATTERY RUNS LOW. NO ONE INVOLVED IN THE EVENT REMEMBERS SEEING THE REMINDER ON THE SCREEN THAT LETS YOU KNOW HOW MUCH BATTERY TIME IS LEFT ON THE PUMP. THE PATIENT DIED 5-6 HOURS LATER, HOWEVER, THE CLINICAL MANAGER FOR THE CCU FEELS THE PUMP PLAYED NO ROLE WITH THE PATIENT'S DEATH. THE CLINICAL MANAGER REPORTED THE PATIENT CODED ABOUT 3 TIMES DURING THE NIGHT AND WAS ON 2 VASOPRESSIVE MEDICATIONS FOR BLOOD PRESSURE (BOTH WERE MAXED OUT), AN IV SOLUTION AT 200ML/HR AND AN AMIODARONE INFUSION FOR THE PATIENTS' ARRHYTHMIAS. CUSTOMER STATES THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS POINT OF CARE UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death FOUR IV SETS: MODEL NUMBERS UNKNOWN| FOUR ALARIS PUMP MODULES: SNS UNKNOWN