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PHYSIO-CONTROL, INC. - 3015876 LUCAS CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL
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| Model Number LUCAS |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Death (1802); Hemorrhage/Bleeding (1888); Rupture (2208); Excessive Tear Production (2235)
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| Event Date 10/12/2018 |
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Event Type
Death
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Manufacturer Narrative
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(b)(4).The device's serial number was not provided.The device was not returned to physio-control for evaluation.Based on the information provided, there was no indication of a device malfunction.Using the information provided in the customer submitted medwatch report, physio-control performed a clinical review of the reported event.Physio determined that the device use may have contributed to the patient's outcome, noting that some of the reported injuries are known to be associated with both manual and mechanical chest compressions.Physio-control has attempted to contact the customer in order to obtain the exact date of the event, the serial number of the device that was used, as well as additional details about the event; however, no response has been received.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
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Event Description
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Physio-control was notified of the following event through customer submitted medwatch report number (b)(4), in which the customer reported the following: "patient found down at home with an unknown down time.Brought to the ed by ems coding.Patient was called as a stemi by the ed and brought to the cath lab.She arrived intubated and on a ventilator.Patient was prepped and draped in the usual fashion.A heart catheterization was performed on the patient.The coronary arteries did not show any blockages.When crossing the aortic valve the patient lost her pulse and blood pressure.Cpr and acls were started.A code blue was called.Ccu nurses, respiratory, and ccm md's arrived to assist.Md called time of death.Injuries found on autopsy due to use of lucas chest compression device.The left subclavian artery had ruptured plaque.There were multiple tears in the pericardial sac with periaortic soft tissue hemorrhage and hemorrhage into both pulmonary hila." neither the exact date of the reported event, nor the serial number of the device used, were provided.
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Manufacturer Narrative
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The customer responded to physio-control's requests for additional information and advised that the event began on (b)(6) 2018.The patient was then pronounced deceased on (b)(6) 2018.The customer further reported the following details about the patient/event: "inpatient cardiology date of service: (b)(6) 2018.Name of procedure: emergent diagnostic cardiac catheterization.Selective bilateral coronary angiography.Attempted left ventricular cineangiography.Cpr.Attempted temporary transvenous pacemaker placement.Clinical history and indication for study: a (b)(6)-year-old female found unresponsive for an unknown period of time, followed by rosc, with pulseless electrical arrest pea cardiac arrest in the setting of significant hypokalemia.Description of procedure: under local anesthesia, a 6-french introducer sheath was placed in right femoral artery.6-french diagnostic jl and jr4 catheters were then utilized for selective bilateral coronary angiography in various projections.A 6-french pigtail catheter was then unsuccessfully advanced across the aortic valve to perform left ventricular cineangiography in a 30-degree rao, as well as a 45-degree lao projection.Patient developed progressive sinus bradycardia and hypotension, followed by asystole despite iv atropine of 1 mg times 2, as well as iv epinephrine of 1 mg.Code blue was initiated.Chest compressions were maintained throughout the cpr.Patient received additional iv epinephrine.Iv levophed was increased to a wide open infusion, followed by initiation of iv epinephrine infusion wide open.However, persistent pea despite all heroic attempts.A 5-french temporary transvenous pacemaker was then advanced to the right atrium under fluoroscopic guidance with complete akinesis of the entire cardiac silhouette.Despite all heroic attempts, including iv potassium as well as iv sodium bicarbonate and the above-mentioned iv pressors with chest compressions, patient expired at 2344.Findings: the initial aortic pressure 145/53 with iv levophed at 0.75 mcg/kg/minute.Coronaries: the left main coronary artery was a large-caliber vessel which appeared to bifurcate into the lad and lcx arteries, but this artery was free of occlusive disease.The lad artery extended around the apex of the left ventricle, giving rise to small to medium-caliber diagonal branches.This artery and its branches were free of occlusive disease.The lcx artery was a nondominant vessel, giving rise to small as well as medium-caliber om branches.This artery's branches were free of occlusive disease.The rca was a dominant vessel, medium to large in caliber, giving rise to a medium-caliber pda as well as posterolateral branch.This artery's branches were free of occlusive disease.Left ventricle: left ventricular cineangiography was unsuccessful in crossing the aortic valve; however, most likely severe global hypokinesis.Impression: status post pea cardiac arrest, with unknown time of unresponsiveness in the field, in the setting of hypokalemia.Normal epicardial coronary arteries.Probable severe left ventricular systolic function.Unsuccessful cpr.Clinical resume date of service: (b)(6) 2018.Admitting diagnoses: pulseless electrical activity (pea) cardiac arrest.Rule out acute inferior lateral st-elevation myocardial infarction (stemi).Clinical resume/death summary procedure note: (b)(6)-year-old female found unresponsive in the field for unknown period of time followed by rosc with pea cardiac arrest in the setting of profound hypokalemia.She was brought emergently to the cath lab at orlando health orlando regional medical center where an emergent diagnostic left cardiac catheterization was performed revealing normal epicardial coronary arteries with probable severe left ventricular systolic function; however, not performed as patient underwent a cardiac arrest during the procedure.She developed vt/vf followed by pea cardiac arrest and cpr was performed with acls protocol management.A 5 french temporary transvenous pacemaker under fluoroscopic guidance was attempted without success.Fluoroscopy of the thorax revealed complete akinesis of the entire cardiac silhouette.Patient expired despite aggressive acls protocol.Impression: ventricular tachycardia (vt)/ventricular fibrillation (vf) and pulseless electrical activity (pea) cardiac arrest with unsuccessful advanced cardiac life support (acls) management.Normal epicardial coronary arteries.Severe systolic left ventricular (lv) dysfunction.Profound hypokalemia.".
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Event Description
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Physio-control was notified of the following event through customer submitted medwatch report number (b)(4), in which the customer reported the following: "patient found down at home with an unknown down time.Brought to the ed by ems coding.Patient was called as a stemi by the ed and brought to the cath lab.She arrived intubated and on a ventilator.Patient was prepped and draped in the usual fashion.A heart catheterization was performed on the patient.The coronary arteries did not show any blockages.When crossing the aortic valve the patient lost her pulse and blood pressure.Cpr and acls were started.A code blue was called.Ccu nurses, respiratory, and ccm md's arrived to assist.Md called time of death.Injuries found on autopsy due to use of lucas chest compression device.The left subclavian artery had ruptured plaque.There were multiple tears in the pericardial sac with periaortic soft tissue hemorrhage and hemorrhage into both pulmonary hila." neither the exact date of the reported event, nor the serial number of the device used, were provided.
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Event Description
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Physio-control was notified of the following event through customer submitted medwatch report number (b)(4), in which the customer reported the following: "patient found down at home with an unknown down time.Brought to the ed by ems coding.Patient was called as a stemi by the ed and brought to the cath lab.She arrived intubated and on a ventilator.Patient was prepped and draped in the usual fashion.A heart catheterization was performed on the patient.The coronary arteries did not show any blockages.When crossing the aortic valve the patient lost her pulse and blood pressure.Cpr and acls were started.A code blue was called.Ccu nurses, respiratory, and ccm md's arrived to assist.Md called time of death.Injuries found on autopsy due to use of lucas chest compression device.The left subclavian artery had ruptured plaque.There were multiple tears in the pericardial sac with periaortic soft tissue hemorrhage and hemorrhage into both pulmonary hila." neither the exact date of the reported event, nor the serial number of the device used, were provided.
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Manufacturer Narrative
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Section d4 model # of the initial medwatch report indicates: blank.Section d4 model #of the initial medwatch report should indicate: lucas.
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