This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.Product event summary: ventricular assist device (vad) (b)(4) was not returned for evaluation.Review of the available auto-logs report revealed a sudden decrease in power consumption and estimated flows logged on (b)(6) 2020 leading to parameters below the normal operating range.10 suction alarms have been logged since (b)(6) 2020 and 2 low flow alarms were logged on (b)(6) 2020.As a result, the reported low flow and suction events were confirmed.Information provided by the site indicated that, in addition to the low flow and suction events, the patient was feeling unwell.The patient was brought to a clinic and swabbed for covid and flu.It was further reported that the patient had been having persistent cough with periods of fatigue.The next day, the patient was found gasping with bulging eyes.Emergency medical services (ems) were called, and they noted the patient to be unresponsive throughout transport.Electrocardiogram was not performed so rhythm at the time of transport was unknown, and the patient was given advanced cardiovascular life support (acls) drugs.Upon arrival to the emergency room (er), the patient coded and of note, was pacemaker dependent.The patient was intubated, and transthoracic echocardiogram (tte) was performed and found very little wall movement/akinesis.Fluids were given in the er and low flows alarms resolved.Neurological assessment in er found absent reflexes and fixed, dilated pupils.A chest x-ray revealed opacities suspicious for bilateral pneumonia.Of note, the patient¿s covid testing results were negative.It was further reported that per family wishes, care was withdrawn and the vad was disabled.The patient subsequently expired, and no autopsy was performed.The patient¿s cause of death was deemed as cardiac arrest.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow and suction events may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, inappropriate pump rotational speed, and/or patient related factors.Per the instructions for use, infection, respiratory dysfunction, neurological dysfunction, cardio-pulmonary arrest and death are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of adverse events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There is possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.
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It was reported that the ventricular assist device (vad) exhibited low flows and suction alarms and the patient was feeling unwell.The patient was brought to a clinic and swabbed for covid and flu.It was further reported that the patient had been having persistent cough with periods of fatigue.The next day, the patient was found gasping with bulging eyes.Emergency medical services (ems) were called, and they noted the patient to be unresponsive throughout transport.Electrocardiogram was not performed so rhythm at the time of transport was unknown, and the patient was given advanced cardiovascular life support (acls) drugs.Upon arrival to the emergency room (er), the patient coded and of note, was pacemaker dependent.The patient was intubated, and transthoracic echocardiogram (tte) was performed and found very little wall movement/akinesis.Fluids were given in the er and low flows alarms resolved.Neurological assessment in er found absent reflexes and fixed, dilated pupils.A chest x-ray revealed opacities suspicious for bilateral pneumonia.Of note, the patient¿s covid testing results were negative.It was further reported that per family wishes, care was withdrawn and the vad was disabled.The patient subsequently expired, and no autopsy was performed.The patient¿s cause of death was deemed as cardiac arrest.
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