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

Model Number TAH-T

Device Problems Air Leak (1008); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

The pt was implanted with the syncardia temporary total artificial heart (tah-t) on (b)(6) 2013, supported by a companion 2 driver.The pt was subsequently enrolled in the freedom driver ide study, switched to a portable freedom driver and discharged to home.On (b)(6) 2014, after 296 implant days, the pt contacted the hospital and reported a tear in his left cannula.The pt was admitted to the hospital, and the customer reported that he examined the cannula and found a small air leak near the end where the cpc connector (a/k/a quick connector) connects the cannula to the freedom driver driveline.The cannula was repaired by removing the cannula from the quick connector, removing the small section of cannula with the tear and re-inserting the cannula into the quick connector.

Manufacturer Narrative

The customer reported that there was no adverse impact on the pt as a result of the cannula crack or the subsequent repair.The pt was observed in the hospital overnight and discharged to home the next day.Syncardia initiated a corrective action (capa) to investigate the root cause of tah-t cannula tears.The investigation is in process.The small section of removed cannula containing the tear was returned to syncardia for evaluation.The results of the evaluation will be provided in a supplemental mdr.

• 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: 3966200
• MDR Text Key: 4748858
• Report Number: 3003761017-2014-00078
• 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: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: TAH-T
• Device Catalogue Number: 500101
• Device Lot Number: 078314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• 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: 52 YR