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

Model Number 595000-001

Device Problems Disconnection (1171); Device Displays Incorrect Message (2591); No Apparent Adverse Event (3189)

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

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited an alarm it continued to perform its life-sustaining functions.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient was out at the mall, heard the freedom driver alarm and stopped to assess the situation.The patient did not find anything wrong with the driver but decided to change to the backup driver.The customer also reported that when the patient went to change the drivelines at the level of the cannula, he noticed that the red driveline cpc connection was disconnected.The cpc was not separated from the cannula.The patient "guessed" that the connection got caught on his jeans and came disconnected.The patient was not light headed nor did he pass out.The patient switched to his backup driver without incident and came to the emergency room.The customer also reported that the hospital circulatory support staff (css) sent the patient home with the driver that had alarmed as his backup driver since the css determined it had operated as intended and alarmed appropriately.When the patient returned for a normal 120-day driver switch, they took the back up driver and gave him a new back up driver.

Manufacturer Narrative

The driver's alarm history was reviewed and revealed a 4a alarm code which was likely produced when either the cpc connection became disconnected (as reported) or when the drivelines were disconnected from the driver during the driver exchange.A 4a alarm becomes latched after 30 seconds of the alarm state.This alarm was reproduced during investigation testing when the left driveline was disconnected from the mock tank.Visual inspection of the driver revealed no abnormalities, and the driver passed all functional testing.Furthermore, no abnormalities were observed on the cpc connectors and they functioned as intended.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: 7227695
• MDR Text Key: 98996018
• Report Number: 3003761017-2018-00026
• 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: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• 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: 01/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR