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

Model Number TAH-T

Device Problems Air Leak (1008); Crack (1135); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 02/20/2014

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) 2013.She was subsequently switched from the css console to a freedom driver and was discharged to home on (b)(6) 2013.The patient was admitted to the hospital on (b)(6) 2014 for renal dysfunction.The customer reported that on (b)(6) 2014, after 310 implant days, the pt informed the nursing staff that her right cannula had an air leak and was making a "hissing" sound.The nursing staff inspected the cannula and observed a crack in the end of the cannula near the quick connector.The cannula was repaired by removing the cannula from the quick connector, removing the small section of cannula with the crack and re-inserting the cannula into the quick connector.

Manufacturer Narrative

The customer reported that there was no reported adverse impact on the patient as a result of the cannula crack or the subsequent repair, and that the small section of removed cannula containing the crack was discarded by the hospital.As of (b)(6) 2014, (b)(4) patients out of (b)(4) syncardia tah-t patients have reported cannula tears, for an occurence rate of (b)(4).Syncardia initiated a corrective action (capa) to investigate the root cause of tah-t cannula tears.The investigation is in process.Syncardia has completed its eval 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.; 1992 e. silverlake rd.; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake rd.; tucson AZ 85713
• Manufacturer Contact: carole marcot, esq ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3737889
• MDR Text Key: 4312253
• Report Number: 3003761017-2014-00040
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2014
• Device Model Number: TAH-T
• Device Catalogue Number: 500101
• Device Lot Number: 073904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2011
• 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: 45 YR