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

Model Number TAH-T

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

The patient was implanted with the syncardia temporary total artificial heart (tah-t) on (b)(6)2012.The patient was subsequently enrolled in the (b)(6) clinical study, and on (b)(6) 2012, he was switched from a companion 2 driver to a (b)(6) and was subsequently discharged to home.On (b)(6) 2013, the customer reported that the spring under the push button in the quick connector of the left tah-t cannula was displaced, preventing him from releasing it from the driver if he had to change drivers.The patient went to the hospital, and the hospital staff replaced the quick connector.There was no adverse impact on the patient as a result of the displacement of the spring in the quick connector.

Manufacturer Narrative

Clinicians are trained to thread a wire tie through the thumb release tab of quick connectors to prevent inadvertent disconnection of the cannulae to the drivelines.It is possible that when the wire tie was threaded through the connector, it dislodged the spring, which became lodged beneath the thumb release tab.Appropriate hospital personnel will be re-trained to avoid spring displacement by not forcing the wire ties into the quick connectors.This alleged failure mode poses a low risk to the patient, because it does not prevent the tah-t system from performing its life-sustaining functions.While it can be difficult to depress the push button to release the quick connectors when the spring is not seated correctly, it is possible to disconnect them by using additional force.The patient was successfully transplanted in (b)(6) of 2013.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: 3647799
• MDR Text Key: 4282608
• Report Number: 3003761017-2014-00002
• 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: Replace
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: TAH-T
• Device Catalogue Number: 500101
• Device Lot Number: 074784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2010
• 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 Age: 65 YR