BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q

    MDR report key: 7291705 · Received February 23, 2018

    Report

    Report Number
    7291705
    Event Type
    Death
    Date Received
    February 23, 2018
    Date of Event
    December 28, 2017
    Report Date
    January 26, 2018
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PREOPERATIVE PLAN WAS TO PLACE AN ON-Q PUMP FOR LOCAL ANESTHESIA. THE ON-Q REPRESENTATIVE WAS PRESENT IN THE OPERATING ROOM TO ASSIST WITH ANY QUESTIONS. PER THE PHYSICIAN DOCUMENTATION: A 2 MM INCISION WAS MADE, THE ON-Q TROCAR WAS THEN ADVANCED IN THE SUBCUTANEOUS TISSUE ABOVE THE FASCIA AND FOLLOWED LATERALLY AND POSTERIORLY TOWARDS THE SCAPULA BY DIRECT PALPATION FOR APPROXIMATELY 8 CM. AFTER THIS WAS WELL POSITIONED, THE TROCAR WAS REMOVED, LEAVING THE SHEATH. THERE WAS NO BLEEDING NOTED. THE ON-Q PUMP TUBING WAS THEN ADVANCED THROUGH THE SHEATH. THE SHEATH WAS THEN WITHDRAWN AND THE CATHETER TUBING APPEARED TO BE IN APPROPRIATE POSITION AND WAS PALPATED IN THE SUBCUTANEOUS SOFT TISSUE. THE CATHETER TUBING WAS ASPIRATED AND THERE WAS NO BLEEDING NOTED, AND THEN 5 ML OF 0.5% BUPIVACAINE WAS INJECTED INTO THE ON-Q TUBING WITH A 5 CC SYRINGE. THIS APPEARED WELL TOLERATED. AN ADDITIONAL 3 ML OF 0.5% BUPIVACAINE WAS INJECTED INTO THE PORT TUBING. THE ON-Q TROCAR WAS THEN ADVANCED SUBCUTANEOUSLY ON THE LEFT AND DEMONSTRATED TO BE SUBCUTANEOUS BY PALPATION. AT THIS POINT THE TROCAR WAS REMOVED LEAVING THE SHEATH AFTER BEING ADVANCED TOWARD THE SCAPULA FOR APPROXIMATELY 8 CM. THE ON-Q TUBING WAS THEN ADVANCED INTO THE SHEATH, AND THE SHEATH WAS THEN WITHDRAWN LEAVING THE ON-Q TUBING IN PLACE. AT THIS POINT, THE ANESTHESIOLOGIST REPORTED THAT THE PATIENT APPEARED TO BE IN ARREST. CHEST COMPRESSIONS WERE INITIATED AND AFTER 4 HOURS OF CPR, THE PATIENT WAS DECLARED DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136245 ON-Q PUMP, INFUSION, ELASTOMERIC MEB HALYARD HEALTH, INC. PM040-A

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death OTHER, ANESTHESIA INDUCTION AND PAIN MEDICATIONS| PATIENT WAS INTUBATED AND HAD IV ANESTHESIA INDUCT