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

Catalog Number 595000-001

Device Problems Low Readings (2460); Device Displays Incorrect Message (2591)

Patient Problems Headache (1880); Blurred Vision (2137); Dizziness (2194)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited a fault alarm two hours after switching to his backup freedom driver s/n (b)(4).The customer also reported that the driver's readings displayed a beat rate (br) of 130, fill volume (fv) 19, and cardiac output (co) of 3.4.The customer also reported that the patient experienced dizziness, blurry vision, and a severe headache during the reported event.The customer also reported that the patient was subsequently switched to another backup freedom driver, where the driver readings displayed a br of 131, fv 52, and co 6.6.There was no reported patient impact after the driver switch.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, the freedom driver continued to perform its life-sustaining functions.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 customer reported that the freedom driver exhibited a fault alarm two hours after switching to his backup freedom driver s/n (b)(4).The customer also reported that the driver's readings displayed a beat rate (br) of 130, fill volume (fv) 19, and cardiac output (co) of 3.4.The customer also reported that the patient experienced dizziness, blurry vision, and a severe headache during the reported event.The customer also reported that the patient was subsequently switched to another backup freedom driver, where the driver readings displayed a br of 131, fv 52, and co 6.6.There was no reported patient impact after the driver switch.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components revealed no abnormalities.Visual inspection of the internal components revealed: a severed shield wire of the secondary motor/gearbox cable assembly.It is unknown how the shield wire became severed but it would not have prevented the secondary motor from operating and is not attributable to the reported issue.There was no evidence of engagement of the secondary motor; the driver operated on the primary motor while it was supporting the patient.Fractured housing bosses at multiple locations.The fractured housing bosses are likely the result from the driver being subjected to an impact shock.The alarm history (eeprom) was reviewed and did not reveal any new permanent fault alarms since the driver was last serviced.The reported fault alarm was not recorded.Only permanent fault alarms are recorded in the alarm history.Intermittent and/or recoverable alarms, such as battery alarms, temperature alarms or fault alarms resolved within three to four minutes, are not recorded in the eeprom.During investigation testing, the driver met all test acceptance criteria while operating on the primary motor, which included normotensive and hypertensive settings, with no anomalies or unintended alarms.The driver was tested for an additional 50.25 hours and performed as intended with no issues.A kink test was performed because the customer reported low fill volumes and low cardiac output.The reported fault alarm was reproduced via this method, suggesting that the potential cause for the patient's symptoms was a result of a kinked driveline that immediately resolved.A low cardiac output alarm will become a permanent fault alarm if it is not resolved within four minutes and fifteen seconds.The alarms resolved during this brief testing and the driver returned to normal operation.During failure investigation testing, the driver performed as intended, and there was no evidence of a device malfunction.The on board batteries utilized by the customer were not returned; therefore, they could not be evaluated during the investigation.The freedom driver was serviced and passed all final performance testing.The reported issue posed a low risk to the patient because although the freedom driver exhibited a fault alarm, the freedom driver continued to perform its life-sustaining functions.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: 5491165
• MDR Text Key: 40265880
• Report Number: 3003761017-2016-00077
• 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: Initial,Followup
• Report Date: 02/24/2016

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: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2012
• 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: 54 YR