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

Catalog Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Positioning Problem (3009)

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

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited a fault alarm while the patient was sitting in his vehicle.The customer also reported that the patient suspected that the freedom driver exhibited a temperature alarm so he exchanged the batteries, held the driver close to the air conditioning, and attempted to improve the ventilation on the backpack that houses the driver.After 2 hours, the driver exhibited another fault alarm.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The customer also reported that the asymptomatic patient was admitted for observation at the emergency room.The customer also reported that the screw on the beat rate door on the freedom driver was damaged, which prevented access to change the rate.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm and the beat rate door screw was damaged, 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 while the patient was sitting in his vehicle.The customer also reported that the patient suspected that the freedom driver exhibited a temperature alarm, so he exchanged the onboard batteries, held the driver close to the air conditioning, and attempted to improve the ventilation on the backpack that housed the driver.After two hours, the driver exhibited another fault alarm.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The customer also reported that the asymptomatic patient was admitted for observation at the emergency room.The customer also reported that the screw on the beat rate door on the freedom driver was damaged, which prevented access to change the rate.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver revealed a damaged potentiometer cover fastening torx screw, which confirmed one of the reported issues.It is unknown how the torx screw became damaged, but it is likely the result of excessive force.Review of the alarm history revealed an alarm code that likely occurred during driver exchange.Only permanent fault alarms are recorded in the alarm history.Intermittent and/or recoverable alarms, such as battery alarms, temperature alarms and fault alarms that are resolved within three to four minutes, are not recorded in the alarm history.The onboard batteries used by the patient at the time of the reported issue were not returned to syncardia and were not evaluated as part of this investigation.The driver was tested and met all test acceptance criteria, which included normotensive and hypertensive settings, with no anomalies or unintended alarms.The driver was then tested for an additional 49.2 hours and performed as intended.The reported fault alarm could not be functionally reproduced during investigation, and there was no evidence of a drift in beat rate.The driver performed as intended, and there was no evidence of a device malfunction.The driver was serviced, which included replacement of the torx screw, and passed all final performance testing.The reported issues posed a low risk to the patient because the freedom driver continued to perform its life-sustaining functions.These issues 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: 5171731
• MDR Text Key: 29345375
• Report Number: 3003761017-2015-00362
• 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: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: No
• 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: 10/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2010
• 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: 36 YR