BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1887148 · Received October 28, 2010

    Report

    Report Number
    2016493-2010-00474
    Event Type
    Death
    Date Received
    October 28, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 1, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER REPORTED, THE PUMP WAS NOT SEQUESTERED AND SERIAL NUMBERS WERE NOT IDENTIFIED. AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENT ON MULTIPLE DRIPS AND WAS ON THE WAY TO THE OPERATING ROOM TO CLOSE HIS CHEST. REPORTED, THE PUMP READ "CHANNEL DISCONNECT" AND THE PUMP TURNED OFF. A HIGH DOSE EPINEPHRINE DRIP WAS RUNNING AT THE TIME ON THIS PUMP. THE SURGEON HAD TO PERFORM CPR WHILE THE ANESTHESIOLOGIST WAS TRYING TO GET THE CHANNEL TO CONNECT AND REPROGRAM IT. THE PATIENT ENDED UP CODING IN THE OPERATING ROOM AND EVENTUALLY DIED LATER. PATIENT WAS VERY SICK AND THIS EVENT PROBABLY DID NOT END HIS LIFE BUT MAY HAVE CONTRIBUTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS SYSTEM PC UNIT SERIAL UNKNOWN