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

Model Number 595000-001

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

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

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited intermittent fault alarms while supporting a patient.The driver alarmed when the patient made large movements such as getting into the car, bending, and reaching for a cup.The customer also reported that the patient reported that the freedom driver "made a different noise than the previous driver." the customer also reported that the patient was 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 intermittent fault alarms, 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

The freedom driver was returned to syncardia for evaluation.The driver passed all test sections and pressure performance metrics associated with normotensive and hypertensive settings.Additionally, an extended observation run was performed, during which the driver functioned as intended with no anomalies or unintended alarms.There was no evidence of a device malfunction.The patient reported that the driver would alarm when bending, reaching, and coughing; therefore, the driver was tested to verify that it functioned as expected by alarming during a valsalva maneuver.During valsalva maneuver testing, the driver functioned as expected by alarming (when cardiac output< 3.5 lpm), and then recovering after the maneuver when co had risen above 3.5 lpm.It is possible that patient conditions caused the driver to alarm, which is the expected function of the driver.The reported issue of a "different" driver noise could not be confirmed during functional testing or extended run testing.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) follow-up report 1.

Event Description

The customer reported that the freedom driver exhibited intermittent fault alarms while supporting a patient.The driver alarmed when the patient made large movements such as getting into the car, bending, and reaching for a cup.The customer also reported that the patient reported that the freedom driver "made a different noise than the previous driver." the customer also reported that the patient was subsequently switched to the 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: 5918242
• MDR Text Key: 54345834
• Report Number: 3003761017-2016-00313
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2013
• 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: 69 YR