Updated description: the customer reported a 54-year-old man with comorbidities of hypertension, type ii diabetes, and recent pancreatitis passed away during a circulatory arrest (cardiac arrest) while cardiopulmonary resuscitation (cpr) was being performed.The lumify device was being used during cpr and the connection cable to the lumify device became loose intermittently.While cpr was continued, another lumify system was obtained to assist with cpr.The first lumify device was used to make the diagnosis of a pericardial effusion causing cardiac tamponade.This pericardial effusion with tamponade was the cause of the cardiac arrest.The first lumify was used to provide visualization for puncturing the pericardial space when the alleged malfunction occurred and visualization was no longer possible.The medical team proceeded with cpr, but it was not possible to perform the pericardial puncture with the first lumify device.The team obtained a second lumify device from a different room and had to first be started up in order to be functional.The period of time between the alleged malfunction of the first lumify and the functional use of the second lumify was estimated by the customer to be ¿several minutes.¿ once the second lumify was in use, the pericardial puncture was continued, and drainage was possible.With this drainage, there was brief return of spontaneous circulation (rosc); however, the attending physician noted that the pericardial space continued to fill with fluid.This scenario then left no further viable therapeutic options, and the patient passed away.The cause of death was determined to be a free wall rupture in subacute myocardial infarction.Preliminary analysis: the sequence of events described by the customer indicates that the alleged malfunction of the first lumify device led to a ¿several-minute¿ delay in achieving pericardial puncture and drainage.The immediate effect of the malfunction of the first lumify was a several minute delay in treating the underlying cause of the cardiac arrest.Once the pericardiocentesis was successful, allowing for initial drainage of the pericardial space, there was a brief moment of rosc, but the pericardial space continued to fill with fluid.There was no cessation of the bleeding from the rupture.The customer stated that there were ¿no further therapeutic options.¿ given the nature of this patient¿s free wall rupture and rapid bleeding from the left ventricle (as evidenced by blood continuing to fill the pericardial space despite drainage), it was determined that there were no therapeutic options to save the patient¿s life.It was the size and nature of the patient¿s free wall rupture that caused the continued bleeding from the rupture site, continued filling of the pericardial space, and failure to maintain spontaneous circulation, not the several minute delay in pericardial puncture caused by the first lumify device.Further, the several minute delay did not contribute to the size and nature of the free wall rupture.The size and nature of the free wall rupture was the cause of the patient¿s shock and cardiac arrest and therefore was already existing when the cardiac arrest began.Thus, even if the first lumify device had not malfunctioned and the pericardial puncture and drainage had taken place without a several minute delay, there would have been continued bleeding filling the pericardial space leaving no therapeutic options for this patient except ¿possibly ¿ immediate surgical intervention, but this was not attempted by the attending medical staff.Based on the series of events described above, the alleged malfunction of the lumify device did not cause or contribute to the patient¿s death in the case.
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