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

Model Number 595000-001

Device Problems Component Falling (1105); Moisture Damage (1405); Failure to Align (2522); Device Displays Incorrect Message (2591); Device Handling Problem (3265)

Patient Problem Loss of consciousness (2418)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(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: freedom driver s/n (b)(4) (mfr report # 3003761017-2017-00082 and 70cc tah-t l/n 101770 cpc connector (mfr report # 3003761017-2017-00083).The customer, a syncardia certified hospital, reported that as the patient reached out, his freedom driver turned over into the sink which had the faucet running and began to exhibit fault alarms after getting wet.The customer also reported that as the patient and friend prepared for a driver switch, the patient was unable to depress and release the left ventricle cpc connector due to a misaligned spring.The customer also reported that while the patient worked to release the cpc connector, the alarming freedom driver stopped and the patient became unconscious for approximately 10-15 seconds.The friend was able to release the cpc connector and successfully switched the patient to the backup freedom driver.Once connected, the patient regained consciousness.The customer also reported that the patient denied any headaches and stated he had some dizziness on the way to hospital but was resolved.The customer also reported that the cpc connector was replaced at the hospital and the patient tolerated the change well.

Manufacturer Narrative

Corrected data: changed to serious injury.The freedom driver was returned to syncardia for evaluation.Visual inspection of the internal components of the driver revealed verdigris and signs of fluid ingress on the housings, signs of liquid ingress evidenced by puddle-like verdigris on the case interior, foreign object debris on the exhaust fan and fan cover, missing intake filter, and secondary motor out of bottom dead center (bdc).The driver in "as received" condition passed test requirements with no anomalies or alarms.Investigation testing was also conducted on the secondary motor circuit and functioned as intended with no issues.Further, an extended observation run testing was performed at the driver's "as received" beat rate setting and the testing did not reproduce the customer-reported issue.Additionally, the onboard batteries used by the customer were evaluated in accordance with freedom onboard battery evaluation procedure and electrically functioned as intended.The customer-reported fault alarm and subsequent driver stop could not be reproduced; therefore, the root cause of the reported issue could not be conclusively determined.It is possible that the driver drop and water ingress described in the customer experience could have been contributing factors to the reported fault condition.The driver was received in a dry condition and syncardia does not have a controlled environment or procedures to test drivers in wet/water conditions.A review of the freedom driver system design failure modes and effects analysis (dfmea) confirmed that hazards associated with driver drops and water ingress have already been assessed and the risks are mitigated as far as possible.Syncardia has also updated labeling to strengthen the wording and cautions regarding freedom driver exposure to drops, rough handling and water ingress.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.Ce (b)(4) follow-up report 1.

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) freedom driver s/n (b)(4) (mfr report # 3003761017-2017-00082 and (2) 70cc tah-t l/n 101770 cpc connector (mfr report # 3003761017-2017-00083).The customer, a syncardia certified hospital, reported that as the patient reached out, his freedom driver turned over into the sink which had the faucet running and began to exhibit fault alarms after getting wet.The customer also reported that as the patient and friend prepared for a driver switch, the patient was unable to depress and release the left ventricle cpc connector due to a misaligned spring.The customer also reported that while the patient worked to release the cpc connector, the alarming freedom driver stopped and the patient became unconscious for approximately 10-15 seconds.The friend was able to release the cpc connector and successfully switched the patient to the backup freedom driver.Once connected, the patient regained consciousness.The customer also reported that the patient denied any headaches and stated he had some dizziness on the way to hospital but was resolved.The customer also reported that the cpc connector was replaced at the hospital and the patient tolerated the change well.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6567294
• MDR Text Key: 75324607
• Report Number: 3003761017-2017-00082
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR