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

Model Number 595000-001

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959); Audible Prompt/Feedback Problem (4020)

Patient Problems No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(6).

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver paused momentarily then restarted with a fault alarm while supporting a patient.The customer also reported that the patient reported not feeling well.The customer also reported that the patient was subsequently switched to a backup freedom driver.

Manufacturer Narrative

Visual inspection of the driver revealed the secondary motor cam follower was out of bottom dead center (bdc) position, indicating engagement of the secondary motor.The driver's alarm history was reviewed and revealed an '0f' alarm code which is produced as a result of primary motor not being engaged.During investigation testing, the customer-reported issue was reproduced and the root cause was determined to be a malfunction of the main printed circuit board assembly (pcba) to operate the primary motor.This led to engagement of the secondary motor, which aligns with the reported brief pause in operation while switching over, and then starting back up with a fault alarm and at a different beat rate, per design.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation 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
• MDR Report Key: 7535686
• MDR Text Key: 108996237
• Report Number: 3003761017-2018-00205
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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: 05/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR