MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 595000-001

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 07/14/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited a red alarm possibly due to the patient's fluid overload condition.The customer also reported that the patient was switched to a circulatory support system (css) console without any adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the driver from performing its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

Testing also determined that the root cause of the reported fault alarm was corrosion of the internal bond wires within the u22 pressure sensor on the main printed circuit board assembly (pcba).Despite the u22 bond wire corrosion and fault alarm, the freedom driver passed all pressure test requirements which included cardiac output (co), pulmonary aortic pressure (pap), arterial pressure (aop) , left atrial pressure (lap) and right atrial pressure (rap) performance metrics associated with nominal normotensive and hypertensive settings.The main pcba was replaced, the driver was serviced and passed all final performance testing.This failure mode posed a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.Syncardia has initiated a corrective action (capa) to address the issue of u22 pressure sensor failures.The investigation is in process.Potential corrective actions will be evaluated when the root cause investigation has been completed.Syncardia has completed its investigation of this complaint and is closing this file.

Event Description

The freedom driver was returned to syncardia for evaluation.Review of the electronic data confirmed the customer- reported with a "bottom pressure too low" fault."bottom pressure too low" faults are typically indicative of a degrading u22 pressure sensor component on the main pcba.During performance testing, the driver exhibited a fault alarm immediately upon startup, duplicating the customer-reported issue.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ 85713
• Manufacturer Contact: carole marcot, esq. svp raq ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4939767
• MDR Text Key: 22563603
• Report Number: 3003761017-2015-00234
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• 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?: Yes
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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