MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

Model Number TAH-T

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problem Loss of consciousness (2418)

Event Date 12/23/2013

Event Type  malfunction  

Event Description

The patient was implanted with the syncardia temporary total artificial heart (tah-t), supported by a circulatory support system (css) console, on (b)(6) 2011.He was subsequently enrolled in the (b)(4) study.He was switched from the css console to a portable freedom driver and was discharged to home on (b)(6) 2011.On (b)(6) 2013, the customer reported that the patient's freedom driver exhibited a fault alarm.The patient reported that he switched to his backup freedom driver, secured the quick connectors with zip ties and went to the hospital for overnight observation, in accordance with the hospital's protocol.The customer reported that while the patient was traveling from his home to the hospital, the quick connectors that connect the tah-t cannulae and the freedom driver drivelines "worked their way loose" and one connector was completely disconnected upon the patient's arrival at the hospital.The patient was reportedly short of breath, was in and out of consciousness upon arrival at the hospital, and became completely unresponsive.The patient was immediately intubated and was switched from the freedom driver to the css console.The customer also reported that the next day, (b)(6) 2013, the patient was awake and fully responsive, and he was extubated later that morning.The patient later reported to the customer that after he switched to his backup freedom driver, he secured the quick connectors with zip ties as usual, but he wasn't sure if he pushed the connectors in far enough when he placed the zip ties, and wasn't sure if he placed the zip ties correctly.The patient also stated that he "sneezed violently" soon after changing to his backup driver and wondered if the physical jerk of his body when he sneezed resulted in the disconnection.The customer reported that there was no permanent adverse impact on the patient as a result of the cannulae/drivelines disconnection.

Manufacturer Narrative

There is no evidence of a device malfunction that caused the disconnection of the tah-t cannulae from the freedom driver drivelines.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3836387
• MDR Text Key: 4453992
• Report Number: 3003761017-2014-00007
• Device Sequence Number: 1
• Product Code: LOZ
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: TAH-T
• Device Catalogue Number: 500101
• Device Lot Number: 072489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2013
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• 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: 44 YR