BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCAS(R) 3 CHEST COMPRESSION SYSTEM

    MDR report key: 6234391 · Received January 9, 2017

    Report

    Report Number
    3015876-2017-00015
    Event Type
    Injury
    Date Received
    January 9, 2017
    Date of Event
    December 4, 2016
    Report Date
    January 3, 2017
    Manufacturer
    JOLIFE AB
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO PERFORMED A CLINICAL REVIEW OF THE INFORMATION THAT WAS REPORTED. THE FOLLOWING ARE THE CONCLUSIONS FROM THE CLINICAL REVIEW: LUCAS PERFORMS COMPRESSIONS ACCORDING THE GUIDELINES FOR MANUAL CPR WITH A DEPTH OF 5 CM AND A RATE OF 100-120 COMPRESSIONS PER MINUTE (SEE FOOTNOTE 1). THE DESCRIBED COMPLICATION, IN THIS CASE, IS KNOWN IN THE PUBLISHED SCIENTIFIC LITERATURE. EPICARDIAL AND PERICARDIAL BLEEDING OCCUR IN 11% - 13% OF PATIENTS WHEN MANUAL CPR OR MECHANICAL CPR HAS BEEN PERFORMED (SEE FOOTNOTE 2). THE PATIENT WAS ON ANTI-THROMBOLYTIC TREATMENT, THIS MAY HAVE CONTRIBUTED TO THE BLEEDING, WHICH WAS CONFIRMED BY THE CUSTOMER.  IT IS LIKELY THAT THE MECHANICAL CHEST COMPRESSIONS MAY HAVE CONTRIBUTED TO THE REPORTED BLEEDING. THE BENEFIT OF POTENTIAL RETURN OF SPONTANEOUS CIRCULATION OUTWEIGHS THE RISK OF COMPLICATIONS FROM CPR. THE PATIENT SURVIVED AND THE BLEEDING DID NOT INFLUENCE THE PATIENT'S OUTCOME. FOOTNOTE 1: HTTP://WWW.LUCAS-CPR.COM/DOC_EN/100901-00_REV_A_LUCAS2_IFU_US_LOWRES.PDF. FOOTNOTE 2: SMEKAL D, ET AL, CPR-RELATED INJURIES AFTER MANUAL OR MECHANICAL CHEST COMPRESSIONS WITH THE  LUCAS DEVICE: A MULTI-CENTER STUDY OF VICTIMS AFTER UNSUCCESSFUL RESUSCITATION, RESUSCITATION 85 (2014) 1708-1712. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. (B)(4). REFERENCE EXEMPTION NUMBER E2014029.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT A PATIENT SUFFERED FROM DETERIORATING CIRCULATION AND PERICARDIAL FLUID COLLECTION, CAUSING TAMPONADE AFTER THEY HAD BEEN TREATED WITH A LUCAS® 3 CHEST COMPRESSION SYSTEM. THE PATIENT HAD COLLAPSED AT THE HOSPITAL AND RESUSCITATION WITH LUCAS WAS INITIATED. AFTER APPROXIMATELY TEN MINUTES RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED. THE PATIENT THEN UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION, A LAD (LEFT ANTERIOR DESCENDING CORONARY ARTERY) ANGIOPLASTY, AND A DRUG ELUTING STENT WAS PLACED. THE SAME EVENING THE PATIENT SUFFERED FROM DETERIORATING CIRCULATION AND PERICARDIAL FLUID COLLECTION, CAUSING TAMPONADE. THIS WAS DIAGNOSED USING ULTRASOUND.  AN EMERGENCY THORACOTOMY WAS DONE, A HEMATOMA WAS REMOVED FROM THE PATIENT'S PERICARDIUM. THE DOCTOR STATED THAT THE PATIENT BEING ON ANTITHROMBOTIC TREATMENT (ACETYLSALICYLIC ACID AND TICAGRELOR AND ENOXAPARIN) HAD PROBABLY CONTRIBUTED TO THE BLEEDING. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15378 LUCAS(R) 3 CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R