BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFESPARC

    MDR report key: 13480062 · Received February 8, 2022

    Report

    Report Number
    13480062
    Event Type
    Death
    Date Received
    February 8, 2022
    Date of Event
    November 30, 2021
    Report Date
    December 14, 2021
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    DWF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PT WAS ON A PROTEK DUO CANNULA AND CARDIOHELP ECMO CIRCUIT. HE WAS CANNULATED THROUGH THE RIGHT INTERNAL JUGULAR VEIN AND THE PUMP WAS DRAINING FROM RIGHT ATRIUM DELIVERING POST OXYGENATION TO THE PULMONARY ARTERY. DURING THE PT'S TIME ON THE PUMP, HE WAS AMBULATORY TO A CHAIR AND EATING/SPEAKING WITH STAFF. AT THE TIME OF THE EVENT, HE HAD NOT BEEN UP WALKING IN 3-4 DAYS BECAUSE OF HIS ANXIETY. HE WAS HAVING COUGHING SPELLS AND FELT LIKE HE WAS SHORT OF BREATH. THE DAY OF THE EVENT HE HAD DONE WELL WITH OXYGENATOR EXCHANGE AND WAS SITTING UP IN BED SHOWING THE ECMO SPECIALIST PICTURES OF HIS CATS. HE HAD A COUGHING SPELL AND LOOKED UP AT HER AS HE YELLED "OUCH" AND BEFORE HE COULD EVEN REACH UP, HE SLUMPED OVER IN BED. CODE WAS INITIATED PER RECORD. PRIOR TO THE EVENT THE PT HAD CANNULA RE-SUTURED AND SECURED AT 1930 WITH AN X-RAY TO FOLLOW (AFTER ANY POSSIBLE MANIPULATION WE VERIFY POSITIONING). CHEST X-RAY SHOWED PROPER PLACEMENT. THE PT CODED AND WE WERE UNABLE TO OBTAIN RETURN OF SPONTANEOUS CIRCULATION AUTOPSY REVEALED THAT THE CANNULA MIGRATED INTO THE RIGHT VENTRICLE CAUSING A PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777408 LIFESPARC CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF CARDIAC ASSIST, INC. 5820-3118

    Patients

    Seq Age Sex Outcome Treatment
    1 11680 DA Male Death