BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM

    MDR report key: 8144646 · Received December 7, 2018

    Report

    Report Number
    0003015876-2018-02088
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    August 1, 2018
    Report Date
    December 7, 2018
    Manufacturer
    JOLIFE AB - 3005445717
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    E2014029. (B)(4). THE DEVICE'S SERIAL NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. USING THE INFORMATION PROVIDED IN THE LITERATURE, PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND AGREED WITH THE AUTHOR'S CONCLUSIONS THAT THE DEVICE USE MAY HAVE CONTRIBUTED TO THE PATIENT'S INJURY. THE AUTHOR CONFIRMED THAT THE LUCAS DEVICE HAD NOT BEEN PLACED ON THE PATIENT IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, NOTING THAT THE LUCAS COMPRESSIONS WERE DELIVERED ON THE REGION OF THE UPPER PART OF THE ABDOMEN DURING PERIODS OF CPR DUE TO THE MALPOSITION OF THE DEVICE ON THE PATIENT. AS A RESULT, PHYSIO-CONTROL CONCLUDED THAT THE LIVER LACERATION MAY HAVE BEEN CAUSED BY MALPOSITION OF THE LUCAS DEVICE ON THE PATIENT. IT IS UNKNOWN IF THE DEVICE STABILIZATION STRAP WAS USED DURING THE REPORTED EVENT. THE USE OF THE DEVICE STABILIZATION STRAP IS INTENDED TO INHIBIT THE DEVICE FROM CHANGING POSITION ONCE PROPERLY POSITIONED ON THE PATIENT'S STERNUM. BASED ON THE INFORMATION PROVIDED, THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. DEVICE NOT EVALUATED BY MANUFACTURER.

    Description of Event or Problem · 0

    PHYSIO-CONTROL PERFORMED A LITERATURE REVIEW (FROM "JOURNAL OF SURGICAL CASE REPORTS", 2018;10, 1¿3) WHICH DESCRIBED THE FOLLOWING EVENT: "A (B)(6) FEMALE INITIALLY PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND BACK PAIN. THE PATIENT HAD RECENTLY TRAVELED TO (B)(6) AND MADE SEVERAL TRIPS TO (B)(6) BY CAR. SHE WAS INITIALLY ALERT AND ORIENTED BUT SUSTAINED A CARDIAC ARREST SHORTLY AFTER ARRIVAL AND UNDERWENT CPR FOR PULSELESS ELECTRICAL ACTIVITY (PEA). APPROXIMATELY 5MIN INTO RESUSCITATIVE EFFORTS, A LUCAS 2.0 (PHYSIO-CONTROL INC.,(B)(4)) DEVICE WAS PLACED FOR CONTINUED CHEST COMPRESSIONS FOR 30MIN. BEDSIDE ECHOCARDIOGRAM SHOWED A DILATED RV WITH A SUSPECTED MASSIVE PE AND THE ECMO TEAM WAS ACTIVATED. THE PATIENT WAS INTUBATED AND VAECMO ACCESS WAS OBTAINED THROUGH THE LEFT FEMORAL ARTERY AND RIGHT COMMON FEMORAL VEIN UNDER ULTRASOUND GUIDANCE WITH 17 FR ARTERIAL AND 25 FR VENOUS CANNULAS (FIG. 1). AFTER A TOTAL OF 35MIN OF CPR, THE PATIENT HAD SPONTANEOUS RETURN OF CIRCULATION. ONCE STABLE, IMAGING CONFIRMED PE (FIG. 2) WITH A RV TO LEFT VENTRICLE (LV) RATIO OF 2.1 (FIG. 3). THE PATIENT WAS THEN ADMITTED TO THE ICU REQUIRING INOTROPIC SUPPORT. APPROXIMATELY 4 H LATER, THE PATIENT HAD CONCERNING FEATURES OF ABDOMINAL COMPARTMENTAL SYNDROME WITH INCREASE ABDOMINAL DISTENTION AND BLADDER PRESSURES >25MMHG WAS NOTED. REPEAT IMAGING SHOWED LARGE VOLUME HEMOPERITONEUM EMANATING FROM THE LEFT HEPATIC LOBE (FIG. 4). THE PATIENT UNDERWENT A DECOMPRESSIVE LAPAROTOMY WITH A NON-ANATOMIC LIVER RESECTION OF SEGMENTS I AND II AND TEMPORARY ABDOMINAL CLOSURE. DUE TO CONCERNS OF DISTAL LIMB ISCHEMIA OF THE ARTERIAL CANNULATION SITE, AN 8-FR REPERFUSION CANNULA WAS PLACED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). POST-OPERATIVELY AFTER 48 H, THE PATIENT WAS CLINICALLY IMPROVING WITH RECOVERY OF HER RV FUNCTION AND OFF INOTROPIC SUPPORT. A BEDSIDE ECHOCARDIOGRAM WAS PERFORMED SHOWING AN RV/LV RATIO OF 1.1. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR REMOVAL OF LIVER PACKS, ABDOMINAL WALL CLOSURE, DECANNULATION OF VA-ECMO, PLACEMENT OF IVC FILTER AND SURGICAL DRAINS BY THE LIVER. THE PATIENT WAS HEMODYNAMIC STABLE POST-OPERATIVELY; OFF INOTROPIC SUPPORT AND STABLE HEMATOCRITS. DESPITE PHYSIOLOGIC IMPROVEMENTS, SHE HAD ALTERED MENTAL STATUS AND LEFT SIDED WEAKNESS. AN MRI OF THE BRAIN SHOWED A SUBACUTE INFARCT OF THE RIGHT CAUDATE LOBE. TWO DAYS AFTER HER FINAL OPERATION, A REPEAT ECHOCARDIOGRAM SHOWED A NORMAL RV FUNCTIONING AND RV/LV RATIO OF 0.7 (FIG. 5). ON POST-OPERATIVE DAY 4 THE PATIENT¿S SURGICAL DRAINS WERE NOTED TO HAVE BLOODY OUTPUT. IMAGING SHOWED A LEFT HEPATIC ARTERY PSEUDOANEURYSM AND UNDERWENT EMBOLIZATION. TWO WEEKS AFTER THE PATIENT¿S INITIAL PRESENTATION, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY AND THE SURGICAL DRAIN WAS REMOVED. FOR OUTPATIENT FOLLOW-UP, SHE CONTINUED TO HAVE MILD LEFT WEAKNESS AND DEPENDENT ON FOR AMBULATION. SHE WAS CONTINUED ON COUMADIN WITH HER IVC FILTER REMAINED IN PLACE AFTER AN UNSUCCESSFUL REMOVAL DUE TO THROMBUS BURDEN." "FOR THIS PATIENT, THE LUCAS WAS POSITIONED WHEN VA-ECMO CANNULATION WAS PERFORMED. THE LUCAS DEVICE WAS MALPOSITIONED WITH DIRECT CONTACT TO THE REGION OF THE UPPER ABDOMEN DURING PERIODS OF CPR. OUR PATIENT SUFFERED A GRADE 4 LIVER LACERATION AFTER MECHANICAL CPR AND ON ANTICOAGULATION." THE SPECIFIC DATE OF THE EVENT WAS NOT PROVIDED, NOR WAS THE SERIAL NUMBER OF THE LUCAS 2 DEVICE USED DURING THE EVENT. THERE HAS BEEN NO INDICATION THAT THERE WAS A MALFUNCTION OF THE LUCAS 2 DEVICE; HOWEVER, THE PATIENT SUSTAINED A SERIOUS INJURY DUE TO THE USE OF THE LUCAS 2 DEVICE, AND THAT THE INJURY REQUIRED MEDICAL INTERVENTION IN ORDER TO PREVENT PERMANENT IMPAIRMENT OR DEATH. THE PATIENT SURVIVED THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981919 LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB - 3005445717 LUCAS 2

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R