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 Problems High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)

Event Date 03/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was asymptomatic, however the patient's systolic blood pressure (sbp) was around 140.The customer also reported that the driver's readings displayed a beat rate of 138 beats per minute (bpm), fill volume (fv) of 65, and a cardiac output (co) of 8.9.The customer also reported that there were no intermittent fault alarms reported and the patient did not notice any fv fluctuations.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.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) follow-up report 1.

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was asymptomatic; however, the patient's systolic blood pressure (sbp) was around 140.The customer also reported that the driver's readings displayed a beat rate of 138 beats per minute (bpm), fill volume (fv) of 65, and a cardiac output (co) of 8.9.The customer also reported that there were no intermittent fault alarms reported and the patient did not notice any fv fluctuations.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's exterior revealed no abnormalities.Review of the alarm history (eeprom) revealed a fault alarm that can be produced: during power cycling of the freedom driver, which can take place at either the clinical site or prior to the electronic reading during the investigation; during onboard battery exchange while operating the freedom driver only on battery power; or if an onboard battery is not fully latched in place, intermittent communication errors can result in a fault alarm.During investigation testing, the driver passed all test acceptance criteria, which included normotensive and hypertensive settings, with no anomalies or unintended alarms.In addition, the driver was tested for an additional 88.5 hours and performed as intended with no issues.The customer-reported fault alarm was not functionally reproduced, the driver performed as intended, and there was no evidence of a device malfunction.The failure investigation could not determine the root cause of the customer-reported fault alarm.The reported fault alarm posed a low risk to the patient because it did not prevent the driver from performing its life-sustaining-functions.This issue will continue to be monitored and trended as part of the customer experience process.This emdr follow-up report 1 also includes (b)(4) syncardia's response to fda request for additional information.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: 5534774
• MDR Text Key: 41777228
• Report Number: 3003761017-2016-00111
• 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: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2012
• 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 Age: 30 YR