MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Model Number 500101-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 12/10/2020

Event Type  Injury  

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.The tah-t cannulae cpc connectors were not returned to syncardia for evaluation.The tah-t cannulae cpc connectors are not connected to the cannulae at syncardia but by the hospital staff after implant.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 (1 of 2).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) 70cc tah-t l/n 119453 (mfr report # 3003761017-2021-00007) and (2) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2021-00015).The customer, a syncardia certified hospital, reported that the patient was found unconscious in the bathroom with both the left and right tah-t cannula cpc connectors disconnected from the freedom driver driveline cpc connectors.The freedom driver alarms alerted the nursing staff.They connected the patient to the backup freedom driver and the patient regained consciousness.The vad coordinators ultimately switched the patient to a companion 2 driver to more closely monitor his volume status.The patient was initially mentally confused for a few days but is reported to be completely back to normal and denies disconnecting the cannulae (cpc connectors).Patient is reported to now be in good spirits and is back to his normal self.(he is a bit non-compliant in eating more salty/fatty foods etc.Than his dietician recommends.) the customer also reported that the zip ties (inserted into the female end of the cpc connectors to prohibit accidental disconnection) were noted to be in proper position and intact by mcs coordinator who had to cut them off, as designed, during the freedom driver exchange.Patient again states that both tah-t cannulae cpc connectors became disconnected from freedom driver driveline cpc connectors simultaneously and he does not have any recollection as to what could have caused this to happen.The customer also reported that they are not alleging any device malfunction with the tah-t cannulae cpc connectors or the freedom driver driveline cpc connectors.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: don webber ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 11181901
• MDR Text Key: 232592799
• Report Number: 3003761017-2021-00007
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 119453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR