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

Model Number TAH-T

Device Problem Device Alarm System (1012)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 10/13/2014

Event Type  malfunction  

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: primary freedom driver, s/n (b)(4) (mfr report# 3003761017-2014-00234) and backup freedom driver, s/n (b)(4) (mfr report# 3003761017-2014-00235).The customer reported that the pt was hypertensive prior to being on the freedom driver and has been on a number of hypertension medications during his entire time on the driver.The customer reported that the pt's primary freedom driver, s/n (b)(4) exhibited a fault alarm while the pt was at home.

Manufacturer Narrative

The customer also reported that while the pt was in the process of switching from his primary freedom driver to his backup freedom driver, he was able to switch his right cannula to the driveline of the backup freedom driver, but he was unable to switch his left cannula because had difficulty disconnecting the left cpc connector, which connects the tah-t cannula and the driver driveline.The pt was temporarily supported by both drivers until he was subsequently able to disconnect the left cpc connector from the driveline of the primary freedom driver and connect his left cannula to the left driveline of his backup freedom driver.The customer also reported that the pt advised that backup freedom driver, s/n (b)(4) exhibited a fault alarm at "start-up" and continued to exhibit a fault alarm after the pt successfully completed the switch from primary driver (b)(4) to backup driver (b)(4).The pt was taken to the hospital by ambulance and was treated for hypertension in the ambulance.The customer also reported that upon arrival, the pt was admitted, treated again for hypertension and was switched to a companion 2 driver.The customer also reported that once the pt was stable, he was switched to another freedom driver.During the switch from the companion 2 driver to the freedom driver, the clinician also had difficulty disconnecting left cpc connector and it was replaced.The customer also reported that the pt remained stable and was discharged to home.There was no reported permanent adverse pt impact as a result of the fault alarms or difficulty switching drivers.Primary freedom driver, s/n (b)(4) will be returned to syncardia for eval.The results of the investigation 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: 4254300
• MDR Text Key: 5045907
• Report Number: 3003761017-2014-00233
• 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: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: TAH-T
• Device Catalogue Number: 500101
• Device Lot Number: 078308
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2014
• 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: 64 YR