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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 09/26/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom driver has been returned to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce 5378; initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm after the patient blew his nose.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.The customer also reported that the patient was admitted to the hospital for hemodialysis that evening and was discharged the following afternoon.The hospital reported that they were attempting to schedule outpatient dialysis 4 times per week instead of 3 times per week.

Manufacturer Narrative

Visual inspection of the driver revealed a cracked display cover, the secondary motor's cam follower out of the bottom dead center (bdc) position, evidence of impact shock between main printed circuit board assembly (pcba) and primary motor and a boss in the front housing pulling out.A '2d' fault alarm was recorded in the driver's eeprom.This alarm is produced as a result of the operation of the secondary motor.Since the secondary motor was observed to be out of the bdc position, it is likely that this is the reported alarm and it was produced because of secondary motor engagement.The conditions that caused the secondary motor cam follower to move out the bdc position cannot be conclusively determined, but it is possible that it occurred due to a drop, near drop, or other rough handling of the driver as evidenced by the physical damage observed during the visual inspection.It could have also been caused by a jolt to the driver while the patient blew his nose as reported by the customer.Despite the observed secondary motor cam follower moved out of bdc position, functional testing confirmed that the driver functioned as intended on both the primary and secondary motor circuits.The driver performed as intended with no evidence of a device malfunction.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5378 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: 10705481
• MDR Text Key: 212326018
• Report Number: 3003761017-2020-00210
• 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
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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: 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: 10/05/2020
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR