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

Catalog Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problems High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

The customer reported that this pt was hypertensive prior to being on the freedom driver and has been on multiple oral agents.The customer also reported that the pt's freedom driver exhibited an irreversible fault alarm while switching onboard batteries.The customer also reported that pt's blood pressure was elevated at the time of the fault alarm.The pt was switched to the backup freedom driver.There was no reported adverse pt impact.The customer also reported that after the pt was switched to the back up driver, the bedside nurse turned on freedom driver 4515 and it did not exhibit a fault alarm.This alleged failure mode poses a low risk to the pt because although the freedom driver exhibited an irreversible 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 a supplemental mdr.

Manufacturer Narrative

During additional testing, the reported fault alarm was duplicated when the driver was not connected to external power and an onboard battery insertion/extraction test was performed.If a freedom driver that is not connected to external power exhibits a fault alarm during onboard battery exchange, the driver will continue to provide its life-sustaining functions.The "freedom driver system guidebook for patients and caregivers" recommends that the freedom driver be connected to an external power source during an onboard battery exchange.The onboard battery insertion/extraction test was performed a second time while the driver was connected to external power.The driver functioned as intended with no alarms.The fault alarm could not be duplicated in this configuration.Visual inspection of the driver's interior components revealed that the potentiometer used to adjust the primary motor beat rate was a non-specified component.The presence of this component in this driver is not related to this complaint.The non-specified potentiometer is functionally equivalent to the specified potentiometer.The potentiometer was replaced with a specified potentiometer.The driver then passed all final performance testing.Syncardia has initiated a corrective action (capa) to address the non-specified potentiometer issue.The capa is in process.The reported fault alarm posed a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.The patient switched to the backup driver without adverse impact.This issue will continue to be monitored and trended through the customer experience process.Syncardia has completed its evaluation of this driver and is closing this file.

Event Description

The freedom driver was returned to syncardia for evaluation.The driver passed all incoming test requirements with no anomalies or alarms.The reported fault alarm was not duplicated during incoming testing.However, review of the alarm history confirmed that a fault alarm occurred while the driver was supporting the patient.

Manufacturer Narrative

Please note that supplemental report 1 reported in additional mfr narrative that "the onboard battery insertion/ extraction test was performed a second time while the driver was connected to external power.The driver functioned as intended with no alarms.The fault alarm could not be duplicated in this configuration." however, it has been removed in this report.Also, the page numbers were corrected in this report.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: CIRCULATORY ASSIST DR
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp ; 5205451234
• MDR Report Key: 4368384
• MDR Text Key: 5265884
• Report Number: 3003761017-2014-00308
• 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 Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2014

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: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2015; 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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: 61 YR