BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS (T) CPR CHEST COMPRESSION SYSTEM

    MDR report key: 3924739 · Received July 1, 2014

    Report

    Report Number
    3005445717-2014-00006
    Event Type
    Death
    Date Received
    July 1, 2014
    Date of Event
    November 1, 2013
    Report Date
    June 27, 2014
    Manufacturer
    JOLIFE AB
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. ACCORDING TO THE CASE REPORT, THE LUCAS DEVICE AND ITS SUCTION CUP WERE PLACED CORRECTLY ON THE CHEST OF THE ASYSTOLIC PATIENT. THERE IS NO REPORT OF MALFUNCTION OF THE DEVICE. THEREFORE, PHYSIO-CONTROL CONCLUDES THAT THE DEVICE WORKED CORRECTLY ACCORDING TO THE TECHNICAL SPECIFICATION, AND HENCE THE DEVICE HAS PERFORMED COMPRESSIONS ACCORDING TO THE ERC GUIDELINES WITH A DEPTH OF 5-6 CM AND A RATE OF 100-120. THIS MEANS THAT THE SIGNIFICANT THICKENING OF THE FREE WALL OF THE RIGHT VENTRICLE, WHICH COULD HAVE BEEN AN EDEMA OR A HEMATOMA, COULD ALSO HAVE OCCURRED WITH MANUAL CPR PERFORMED ACCORDING TO GUIDELINES. THE CASE REPORT STIPULATES THE HEART WAS TWISTED A BIT, SO THE COMPRESSION POINT ACCORDING TO GUIDELINES WAS MORE ON THE RIGHT SIDE OF THE HEART INSTEAD OF OVER BOTH VENTRICLES (REFERENCE 1, 2). IT IS KNOWN THAT THERE ARE ANATOMIC DIFFERENCES BETWEEN PATIENTS (REFERENCE 3). THOSE ANATOMIC DIFFERENCES ARE NOT TAKEN INTO CONSIDERATION IN THE GUIDELINES. INJURIES TO THE HEART AND THE GREAT VESSELS HAPPENS IN ABOUT 11% OF THE CASES WITH MANUAL CPR (REFERENCE 4). THERE IS NO SUCH REVIEW FOR MECHANICAL CPR AVAILABLE, BUT IT COULD HAPPEN (REFERENCE 5). THE SIGNIFICANT THICKENING OF THE FREE WALL OF THE RIGHT VENTRICLE, WHICH COULD HAVE BEEN AN EDEMA OR A HEMATOMA ON A TWISTED HEART, IS PROBABLY CAUSED BY THE PROVIDED CPR. THE PATIENT SEEMS TO HAVE AN ANATOMICAL UNUSUAL PLACEMENT OF THE HEART WHICH MAY HAE CONTRIBUTED TO THE REPORTED THICKENING OF THE FREE WALL. EVEN IN CASES WERE THE HEART IS NOT TWISTED, INJURIES OF THE HEART AND GREAT VESSELS ARE REPORTED ADVERSE EVENTS DURING MANUAL CPR AND MAY SIMILARLY OCCUR WITH MECHANICAL CPR WHEN PERFORMED ACCORDING TO ERC GUIDELINES.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED IN AN ARTICLE PUBLISHED IN THE "ANNALS OF EMERGENCY MEDICINE 2014.01.020." AMBULANCE PERSONNEL ATTENDED TO (B)(6) YEAR OLD MALE COMPLAINING OF CHEST PAIN. IN THE AMBULANCE, THE PATIENT PRESENTED AN ACUTE PULMONARY EDEMA, FOLLOWED BY A SUDDEN CARDIAC ARREST. THE LUCAS 2 DEVICE WAS USED IMMEDIATELY TO ADMINISTER CHECK COMPRESSIONS. IN ADDITION TO THAT, THE PATIENT RECEIVED INTRAVENOUS EPINEPHRINE AND WAS SUBSEQUENTLY TRANSFERRED TO THE CATHETERIZATION LAB 15 MINUTES AFTER THE INITIAL CARDIAC ARREST. THE PATIENT'S RHYTHM WAS ASYSTOLIC. THE PATIENT WAS DETERMINED TO BE A CANDIDATE FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY. DURING THE ECMO IMPLANTATION, IT WAS OBSERVED THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAPHY THAT THE CHEST COMPRESSIONS WITH THE LUCAS 2 DEVICE WERE INEFFECTIVE (ECHOCARDIOGRAPHY SHOWED INEFFECTIVE COMPRESSION ON THE LEFT VENTRICLE WITH AN ISOLATED COMPRESSION OF THE RIGHT VENTRICLE). A SECOND TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED A SIGNIFICANT THICKENING OF THE FREE WALL OF THE RIGHT VENTRICLE WHICH COULD HAVE BEEN AN EDEMA OR A HEMATOMA. THESE FINDINGS MAY HAVE BEEN RELATED TO A TRAUMATIC IMPAIRMENT OF THE RIGHT VENTRICLE, CAUSED BY THE LUCAS 2 CHEST COMPRESSION DURING THE INITIAL CPR. AFTER 6 HOURS OF FULL INTENSIVE CARE, THE PATIENT DEVELOPED A SEVERE ISCHEMIA-REPERFUSION SYNDROME ASSOCIATED WITH MULTIPLE ORGAN FAILURE. THE PHYSICIANS IN CHARGE DECIDED, TOGETHER WITH THE FAMILY, TO PROCEED TOWARD A THERAPEUTIC WITHDRAWAL AND THE PATIENT DIED. ATTEMPTS TO GATHER ADDITIONAL INFORMATION FROM THE AUTHOR HAVE BEEN UNSUCCESSFUL. THIS REPORT HAS BEEN PREVIOUSLY REPORTED BY PHYSIO-CONTROL, INC. UNDER MANUFACTURER REPORT # 3015876-2014-00321.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381614 LUCAS (T) CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death