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

Catalog Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Torn Material (3024); Noise, Audible (3273)

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

Event Date 09/18/2015

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: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00309) and (2) 70cc tah-t cannula s/n (b)(4) (mfr report # 3003761017-2015-00310).The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that there is a small tear on the tah-t cannula that is located near the cpc connector on the left cannula.The customer also reported that the patient was subsequently switched to the backup freedom driver and the 70cc tah-t cannula was repaired.There was no reported adverse patient impact during the switch to the backup freedom driver or as a result of the cannula tear and subsequent repair.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm and a cannula tear, the freedom driver continued to perform its life-sustaining functions.Syncardia has initiated a capa (corrective or preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.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, associated with (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 # 3003761017-2015-00309) and 70cc tah-t cannula s/n (b)(4) (mfr report # 3003761017-2015-00310).The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that there is a small tear on the tah-t cannula that is located near the cpc connector on the left cannula.The customer also reported that the patient was subsequently switched to the backup freedom driver and the 70cc tah-t cannula was repaired.There was no reported adverse patient impact during the switch to the backup freedom driver or as a result of the cannula tear and subsequent repair.The damaged section of the 70cc tah-t cannula s/n (b)(4) was not returned to syncardia for investigation since the customer disposed of the damaged section of cannula.Syncardia has initiated a capa (corrective or preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.As of (b)(6) 2016, the patient received a donor heart transplant.The freedom driver s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no abnormalities.Visual inspection of the driver's internal components revealed a raised bottom right housing boss insert.The raised bottom right housing boss insert did not cause any unintended alarm during investigation testing.The driver in "as received" condition passed all test requirements, which included testing at normotensive and hypertensive settings, with no anomalies or unintended alarms.An onboard battery charge/discharge test was performed, and the driver performed as expected.The driver's electronics functioned as intended and were capable of detecting the external power supply voltage with no alarms or issues.The electronic alarm history did not reveal any permanent fault alarms related to low cardiac output.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.The electronic alarm history revealed one fault code (fault code 47), which indicated that a lower input voltage from the external power source was present relative to the onboard batteries' voltage for a period exceeding five minutes.By design per, syncardia tah-t freedom driver system software requirements specification, this will trigger a permanent fault alarm.This fault code is indicative of an issue with the external power source.During investigation testing, the customer-reported fault alarm could not be reproduced, and there was no evidence of a device malfunction.With the provided information from the customer experience and the investigation results, the permanent alarm was likely caused by a connection issue with an external power source (via ac power supply connected to a wall power outlet or a 12v vehicle power outlet).The cannula tear as reported by the customer could have resulted in an intermittent temporary fault alarm but did not persist long enough (four minutes and fifteen seconds) to become recorded in the electronic alarm history.A low cardiac output fault alarm would also be recorded before fault code 47, which requires a five-minute duration to be recorded in the electronic alarm history.The customer-reported fault alarm posed a low risk to the patient because the driver continued to perform its life-sustaining functions.The freedom driver can be powered by the onboard batteries or an external power source (grounded wall power outlet or 12v vehicle power outlet).Per syncardia's freedom driver system guidebook for patients and caregivers - us, section 7.4, fault alarms must be immediately addressed by any of the following: (i) relaxing/interrupting the valsalva maneuver, (ii) managing elevated systolic blood pressure as directed by the physician, (iii) undoing any kinks in the drivelines, (iv) reconnecting the drivelines and cannulae, or (v) checking the charge of the onboard batteries and to replace them, if necessary.If a fault alarm cannot be resolved, the patient must switch to a backup driver.The driver was serviced, which included the replacement of the housings, before being placed 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 Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5111911
• MDR Text Key: 27144521
• Report Number: 3003761017-2015-00309
• 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: Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• 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: 09/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2012
• 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: 58 YR