BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBU ACTION BLOCK PAIN PUMP DISPOSABLE...

    MDR report key: 3929747 · Received June 18, 2014

    Report

    Report Number
    3929747
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    AMBU, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AMBU ACTION BLOCK PAIN PUMP DISPOSABLE PAIN MANAGEMENT SYSTEM (AABPDPM) PUMP (SOMETIMES CALLED A BALLOON) WAS FILLED WITH BUPIVACINE 1625MH/650ML FOR POST OP FEMORAL BLOCK FOLLOWING TOTAL KNEE ARTHROPLASTY. CATHETER WAS INSERTED BY ANESTHESIA FOR FEMORAL NERVE BLOCK IN PACU. PUMP CONTAINING BUPIVACAINE AND ATTACHED TUBING WERE PRIMED, CONNECTED TO CATHETER PORT AND UNCLAMPED FOR ADMINISTRATION BY SURGICAL UNIT RN. NURSE WAS ACCUSTOMED TO A DIFFERENT PUMP WITH A BUILT-IN FLOW METER THAT DELIVERED 5ML/HR. THE AABPDPM HAS A SEPARATELY-PACKAGED BLOCK-PUMP THAT IS MEANT TO ATTACH BETWEEN THE PUMP TUBING AND THE CATHETER PORT. THE BLOCK-PUMP KIT REGULATES FLOW RATE. RN DID NOT NOTICE THE ABSENCE OF A FLOW METER. THERE IS NO BARRIER IN PLACE TO PREVENT PUMP TUBING FROM CONNECTING DIRECTLY TO CATHETER PORT. PATIENT RECEIVED BUPIVACAINE VIA FEMORAL NERVE CATHETER AT AN UNREGULATED ATE. MEDICATION WAS STARTED AT 1456. AT APPROXIMATELY 1700, PATIENT COMPLAINED OF NUMBNESS IN ARMS AND TONGUE, ROOM SPINNING, AND SLIGHT NAUSEA. PATIENT DEVELOPED DIFFICULTY FOCUSING AND ANSWERING QUESTIONS, SEIZURE-LIKE ACTIVITY, AND DIFFICULTY BREATHING. CPR STARTED AT 1720. PATIENT PRONOUNCED DEAD AT 1929. DEVICE SENT TO OFFICE OF MEDICAL EXAMINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356721 AMBU ACTION BLOCK PAIN PUMP DISPOSABLE... PAIN MANAGEMENT SYSTEM FRN AMBU, INC. 16471802

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death