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

Catalog Number 595000-001

Device Problems Device Alarm System (1012); Filling Problem (1233); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited fluctuating fill volumes and output while supporting a patient.The customer also reported that the patient had intermittent fault alarms.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 fluctuating fill volumes and intermittent fault alarms, 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 fluctuating fill volumes and output while supporting a patient.The customer also reported that the patient had intermittent fault alarms.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.Visual inspection of the driver's external components revealed no abnormalities.Visual inspection of the driver's internal components revealed multiple fractures on three of the bosses of the front housing.The bosses could have fractured as a result of normal use and are not the cause of the customer-reported issue.The front housing will be replaced upon servicing of the driver.The driver's electronic alarm history data was retrieved, there were no new alarms recorded.Only permanent fault alarms are recorded in the driver's alarm history.Intermittent, recoverable and battery alarms are not recorded in the electronic alarm history data.The driver in "as received" condition passed all test requirements associated with normotensive and hypertensive settings with no anomalies or alarms.The driver was tested for an additional 48 hours, and the driver functioned as intended with no alarms or anomalies in fill volumes and cardiac output.It is likely that the customer-reported issues were the result of the patient's condition at the time of the customer experience.The driver performed as intended, and there was no evidence of a device malfunction.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited fluctuating fill volumes and intermittent fault alarms, the freedom driver continued to perform its life-sustaining functions.The freedom driver was serviced and passed all functional and performance testing prior to being released 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 (Section G): 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: 5059321
• MDR Text Key: 25790760
• Report Number: 3003761017-2015-00277
• 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: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/31/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2015
• Initial Date FDA Received: 09/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• 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: 26 YR