Model Number 500101-001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Death (1802); Sepsis (2067)
|
Event Date 07/06/2020 |
Event Type
Death
|
Manufacturer Narrative
|
The syncardia 70cc 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 70cc 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 investigation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4) initial.
|
|
Event Description
|
The customer, a syncardia certified hospital, reported that the patient received inpatient dialysis and 4 liters were taken off.The nurse practitioner noted that the patient was septic and febrile.The hospital team reported that the infection is most likely due to the dialysis catheter and would monitor the patient.
|
|
Event Description
|
On (b)(6) 2020, the customer reported that the patient passed away on (b)(6) 2020, with the cause of death listed as sepsis.The customer indicated that the device caused or contributed to the patient death as the pump was seeded with an infection that couldn't be cleared.The customer also reported that the tah-t was not explanted and no autopsy was performed.No additional information has been provided at this time.
|
|
Manufacturer Narrative
|
The hospital did not, and will not in the future, culture the tah-t to confirm if the pump was infact seeded with an infection that couldnt be cleared.The syncardia 70cc 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 70cc 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.A definitive root cause cannot be conclusively determined.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4), follow-up report 1.
|
|
Search Alerts/Recalls
|