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

Catalog Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/27/2015

Event Type  malfunction  

Manufacturer Narrative

(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: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00442 and backup freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00443).The customer reported that the primary freedom driver s/n (b)(4) exhibited an irreversible fault alarm after the patient had a forceful cough.The customer also reported that driver s/n (b)(4) had the following readings during the reported event: beat rate (br) 131, fill volume (fv) 49.1, and cardiac output (co) 6.8.The customer also reported that the patient was subsequently switched to the backup freedom driver s/n (b)(4).The driver s/n (b)(4) readings were as follows: br 130, fv 51.2, and co 7.1.The customer also reported that the backup freedom driver s/n (b)(4) exhibited an irreversible fault alarm after the patient had another coughing episode.The customer also reported that the patient was instructed by the hospital to return to the primary freedom driver s/n (b)(4) after the hospital staff confirmed the driver was functioning normally.The customer also reported that the patient arrived at the hospital where the hospital staff confirmed the patient was stable and the driver and cannulae were intact and had no issues.The customer also reported that the primary freedom driver s/n (b)(4) exhibited another fault alarm when the patient was instructed to cough.The customer also reported that the patient was subsequently switched to another 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 fault alarms, the freedom driver continued to perform its life-sustaining functions.The freedom driver s/n (b)(4) and s/n (b)(4) will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.Visual inspection of the internal components of the driver revealed the cam follower on the secondary motor out of bottom dead center (bdc) position.Review of the electronic data revealed two permanent alarms, fault code 2d, which corresponds to a "secondary motor voltage too high" fault condition.This fault condition was confirmed through investigation testing and the observation of the cam follower on the secondary motor out of bdc position, which is indicative of an operation switch to the secondary motor.The driver in "as received" condition passed all test requirements, while operating on the primary motor, with no anomalies or unintended alarms.The customer-reported issue was not reproduced during incoming inspection testing.Because the internal visual inspection revealed the cam follower on the secondary motor was out of bdc position, the driver was also tested on the secondary motor and exhibited an alarm, as expected.Despite the fault alarm, the driver passed all test requirements with no anomalies.The customer-reported fault alarm was reproduced only as a result of a deliberate operation switch to the secondary motor.Despite the customer-reported fault alarm, there was no evidence of a device malfunction.The driver experienced a fault alarm as a result of an operation switch to the secondary motor as indicated by the cam follower on the secondary motor being out of bottom dead center position.Although it could be attributed to the patient conditions (forceful coughing) at the time of the event, there was no evidence to conclusively determine why the driver switched operation to the secondary motor.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.(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: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00442 and backup freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00443).The customer reported that the primary freedom driver s/n (b)(4) exhibited an irreversible fault alarm after the patient had a forceful cough.The customer also reported that driver s/n (b)(4) had the following readings during the reported event: beat rate (br) 131, fill volume (fv) 49.1, and cardiac output (co) 6.8.The customer also reported that the patient was subsequently switched to the backup freedom driver s/n (b)(4).The driver s/n (b)(4) readings were as follows: br 130, fv 51.2, and co 7.1.The customer also reported that the backup freedom driver s/n (b)(4) exhibited an irreversible fault alarm after the patient had another coughing episode.The customer also reported that the patient was instructed by the hospital to return to the primary freedom driver s/n (b)(4) after the hospital staff confirmed the driver was functioning normally.The customer also reported that the patient arrived at the hospital where the hospital staff confirmed the patient was stable and the driver and cannulae were intact and had no issues.The customer also reported that the primary freedom driver s/n (b)(4) exhibited another fault alarm when the patient was instructed to cough.The customer also reported that the patient was subsequently switched to another backup freedom driver.There was no reported adverse patient impact.

• 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: 5340202
• MDR Text Key: 35352379
• Report Number: 3003761017-2015-00442
• 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: 12/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• 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: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2012
• 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: 65 YR