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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue did not prevent the driver from performing its life-sustaining function.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver had been in the patient's car in approximately 19 degree fahrenheit temperatures for 2.5 hours prior to being put on patient support.As his wife pressed the display button to show the beat rate, cardiac output and fill volume readings, the screen was blank; the display was streaky grey and black without any numbers/letters displayed.After arriving home, the freedom driver would display the readings intermittently.The customer also reported that the freedom driver did not exhibit any fault alarms until the patient went to bed that night.It exhibited intermittent alarms whenever the patient changed from a prone position to sitting position throughout the night, but they were very brief.In the morning of (b)(6) 2018 as the patient sat up to the edge of the bed, the freedom driver exhibited a permanent fault alarm.The patient's wife checked the drivelines and switched batteries but the alarm continued.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of the driver revealed a fractured display cover, a broken exhaust fan cover, a missing rubber foot, the secondary motor cam follower out of the bottom dead center (bdc) position, and a broken scotch yoke on the secondary side of the piston cylinder assembly (pca).The driver alarm history was reviewed and revealed the presence of one new alarm, a 2d which correlates with the secondary motor cam follower being out of bdc.The customer-reported lcd display not working was determined to be caused by button depression difficulty, likely caused by an impact shock/rough handling as evidenced by the fractured display cover.Despite the damage, the button was able to be depressed during investigation, albeit harder than normal force was required to do so.Despite the observed damage, the driver passed all functional criteria during investigation testing.Note: the pca's yoke is broken on the secondary side which allows for the functional test to be normally performed.The customer-reported fault alarm was likely caused by secondary motor operation, as evidenced by the secondary motor cam follower being out of bdc.It is unknown when the scotch yoke on the secondary side broke, but it is likely after the driver was removed from the patient.The motor cam follower may have been initially moved out of bdc position because of a drop, near drop or other rough handling as evidenced by the damage observed during the visual inspection.The reported temperature that the driver and onboard batteries were exposed to was outside of the recommended operating range (below 40°f for the driver and 32°f for the onboard batteries), but within the transportation/storage temperature range which goes down to -13°f.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.Ce 4583 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNUEMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8148389
• MDR Text Key: 130655733
• Report Number: 3003761017-2018-00547
• 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: 02/28/2019

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: 12/05/2018
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR