MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Loss of consciousness (2418)

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) primary freedom driver s/n 4547 (mfr report # 3003761017-2015-00327 and (2) freedom onboard battery s/n 45337 (mfr report # 3003761017-2015-00350).The customer reported that on (b)(6) 2015, the freedom driver exhibited a fault alarm while supporting a patient that was working in his garage.The customer also reported that the patient immediately changed the freedom onboard batteries and the alarm resolved.The customer also reported that one of the four batteries, freedom onboard battery s/n (b)(4), only had one bar remaining of power at the time of the event.The patient reported that there was no battery alarm and that the freedom onboard battery s/n (b)(4) was fully charged 30 minutes prior to the fault alarm.The customer also reported that on (b)(6) 2015, the freedom driver exhibited another fault alarm with freedom onboard battery s/n (b)(4) while the patient was out shopping with his spouse.Freedom onboard battery s/n (b)(4) went from fully charged to one bar without a battery alarm prior to the fault alarm.The patient switched out the battery and the alarm resolved and the patient continued shopping.The customer also reported that while the patient and his spouse were loading up the car, the patient reported "not feeling well" and the freedom driver exhibited a fault alarm.At the same time of the fault alarm, the patient lost consciousness while sitting in his vehicle.The customer also reported that the patient regained consciousness after approximately 30 seconds.The patient was subsequently switched to the backup freedom driver.The patient felt fine after the driver switch.The customer also reported that the patient was assessed by the medical staff and was alert, oriented, stable, and able to walk without issue.The patient denied having any shortness of breath or any other symptoms.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00327 and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00350).The customer reported that on october 2, 2015, the freedom driver exhibited a fault alarm while supporting a patient that was working in his garage.The customer also reported that the patient immediately changed the freedom onboard batteries and the alarm resolved.The customer also reported that one of the four batteries, freedom onboard battery s/n (b)(4), only had one bar remaining of power at the time of the event.The patient reported that there was no battery alarm and that the freedom onboard battery s/n (b)(4) was fully charged 30 minutes prior to the fault alarm.The customer also reported that on october 3, 2015, the freedom driver exhibited another fault alarm with freedom onboard battery s/n (b)(4) while the patient was out shopping with his spouse.Freedom onboard battery s/n (b)(4) went from fully charged to one bar without a battery alarm prior to the fault alarm.The patient switched out the battery and the alarm resolved and the patient continued shopping.The customer also reported that while the patient and his spouse were loading up the car, the patient reported "not feeling well" and the freedom driver exhibited a fault alarm.At the same time of the fault alarm, the patient lost consciousness while sitting in his vehicle.The customer also reported that the patient regained consciousness after approximately 30 seconds.The patient was subsequently switched to the backup freedom driver.The patient felt fine after the driver switch.The customer also reported that the patient was assessed by the medical staff and was alert, oriented, stable, and able to walk without issue.The patient denied having any shortness of breath or any other symptoms.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no abnormalities.Review of the alarm history electronic data confirmed that the driver did not record a permanent fault alarm while supporting the patient.Only permanent fault alarms are latched in the electronic record.Intermittent, recoverable, and battery alarms are not recorded.In addition, there was no evidence in the electronic data that the driver stopped pumping.If the driver had stopped pumping, there would have been a fault code of "bottom dead center (bdc) timeout" or "top dead center (tdc) timeout,", which are reflective of the lack of movement of the piston and cylinder assembly.The driver in "as received" condition passed all required functional testing requirements, which included normotensive and hypertensive settings, with no anomalies or alarms.The driver was tested for an additional 50 hours, and the driver performed as intended with no evidence of a device malfunction.The investigation concluded that there was no evidence of a driver malfunction, and there was no evidence that the driver stopped pumping.The cause of the patient's loss of consciousness after onboard battery s/n (b)(4) was exchanged could not be determined.Despite the customer-reported fault alarm, risk to the patient was low because the driver continued to perform its life-sustaining functions.The patient was switched to the backup driver with no reported adverse impact.The driver was serviced, which included the replacement of the main printed circuit board assembly (pcba), speaker pcba, motor/gearbox assemblies, motor controller pcba and piston cylinder assembly (pca) before being placed into finished goods.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 FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5141663
• MDR Text Key: 28376905
• Report Number: 3003761017-2015-00327
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 10/04/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 66 YR