Model Number 500101-001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Septic Shock (2068); Multiple Organ Failure (3261)
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Event Date 11/06/2021 |
Event Type
Death
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Event Description
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The customer, a syncardia authorized distributor, reported that the patient passed away on (b)(6) 2021.The customer reported the cause of death as septic shock.No additional information has been provided at this time.
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Manufacturer Narrative
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The syncardia 70 cc temporary total artificial heart (tah-t) is an implantable pulsatile biventricular replacement device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation systems.The syncardia 70 cc tah-t is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.The syncardia tah-t system is intended for use inside and outside the hospital.Based on the provided information there is no evidence to indicate any device malfunctions or performance issues of the device that would impact the reported event.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).
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Manufacturer Narrative
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Additional information and corrected information in section b5.Corrected health effect - clinical code in section h6.
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Event Description
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The customer, a syncardia authorized distributor, reported that the patient passed away on (b)(6) 2021.The customer reported the cause of death as multi-organ system failure and that the device did not cause or contribute to the patient death.No autopsy was performed and the tah-t was not explanted.
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Search Alerts/Recalls
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