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

Model Number 595000-001

Device Problems Output Problem (3005); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce 5375; initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver display was reading cardiac output of 8.0-8.5 lpm, and the patient reported he had increased chest pressure since the most recent change out of his freedom driver.No alarms were reported with the device.After an additional dose of diuretics earlier in the day and troubleshooting with ensuring no kinks in the drivelines, or abnormal placement of the cannulas, hospital staff decided to change to the backup freedom driver since the patient was also experiencing mild anxiety due to the feeling he was having since the previous change out.There was no reported adverse patient impact.

Manufacturer Narrative

The driver passed all sections of functional testing.Increased cardiac output (co) can be caused by a faulty air flow sensor cable.Investigation testing determined that the air flow sensor cable worked as intended as the co readings remained within acceptable tolerance even while the cable was moved and flexed.It is noted that as part of normal operation, the driver displays a co above 8.0 briefly on startup, however it immediately settles to acceptable tolerance averaging 6.6 co lpm within 2 minutes, and maintains this level of cardiac output.The root cause of the customer-reported increased cardiac output and user dissatisfaction could not be conclusively determined.The freedom driver performed as intended with no evidence of a device malfunction.This issue will be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

• 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 (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10705489
• MDR Text Key: 212329844
• Report Number: 3003761017-2020-00207
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2017
• 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: 32 YR
• Patient Sex: Male