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

Model Number 595000-001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

Neither the freedom driver nor the broken beat rate adjustment cover were returned to syncardia for evaluation; therefore an investigation was not able to be performed and a root cause for the observed damage could not be conclusively determined.Based on previous investigations, the damage is most likely the result of over tightening the fastening screw.The fastening screw is first applied at syncardia during servicing, and is removed by the customer at the hospital to adjust and set the beat rate specific to the patient being supported by the driver.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4).

Event Description

The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver beat rate adjustment cover was damaged upon receipt.The customer also reported that a replacement cover was provided by syncardia and installed on the freedom driver.

• 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: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 8985318
• MDR Text Key: 158701770
• Report Number: 3003761017-2019-00261
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2019

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: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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