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

Catalog Number 595000-001

Device Problems Filling Problem (1233); Device Displays Incorrect Message (2591); 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 customer reported that the freedom driver exhibited a red fault alarm while supporting a patient.The customer also reported that at the same time of the fault alarm, the freedom driver exhibited decreased fill volumes that displayed amounts under 20 milliliters.The customer also reported that the patient 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 red 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).

Event Description

The customer reported that the freedom driver exhibited a red fault alarm while supporting a patient.The customer also reported that at the same time of the fault alarm, the freedom driver exhibited decreased fill volumes that displayed amounts under 20 milliliters.The customer also reported that the patient 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 external components revealed no abnormalities.Visual inspection of the driver's internal components revealed fractured housing bosses.It is unknown how the housing bosses were fractured but the damaged observed is consistent with an impact shock.The electronic data record did not reveal any new permanent fault alarms that occurred while the driver was supporting the patient.Only permanent fault alarms are recorded in the driver's alarm history.Intermittent, recoverable and battery alarms are not recorded in the electronic data.The driver in "as received" condition passed all test acceptance criteria, which included testing with normotensive and hypertensive settings, with no anomalies, no alarms, and no indications of a decreased fill volume.The driver was tested for an additional 48 hours and performed as intended with no alarms or indications of a decreased fill volume.The customer-reported fault alarm and decreased fill volume could not be functionally reproduced during investigation testing, and the root cause could not be determined.During investigation testing, the driver performed as intended, and there was no evidence of a device malfunction.Despite the customer-reported issues, risk to the patient was low because the driver continued to perform its life-sustaining-functions.The driver was serviced.Based on days of use, the service included the replacement of the piston and cylinder assembly (pca), housings, motor/gearbox assembly, motor controller printed circuit board assembly (pcba), and speaker pcba 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: 5101674
• MDR Text Key: 26846899
• Report Number: 3003761017-2015-00308
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• 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

• 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: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2012
• 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: 45 YR