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

Catalog Number 595000-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the reported issue was observed when the freedom driver was supporting a patient, it did not prevent the device from performing its life-sustaining functions.The freedom driver has been returned to syncardia and will be evaluated.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 battery light on the freedom driver was "dim, not blinking" while supporting a patient.The customer also reported that the patient was switched to a backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of the external and internal components of the driver revealed a broken connector on the connection 1 receptacle cable, a broken connector on the power adaptor attached to the driver, and raised inserts on right top and right bottom housing bosses.The customer-reported issue was confirmed prior to functional testing when an electrical connection could not be established between the connection 1 receptacle and the power adaptor, which were both observed to have physical damage.When the driver was first powered, there was no electrical connection between the power adaptor and the connection1 receptacle cable.This confirmed the reported issue as the inserted onboard batteries will not blink when ac power is not connected.After securing a reliable electrical connection between the power adaptor and the driver's receptacle cable, the freedom driver passed all sections of functional testing.Additionally, an onboard battery recharge test was performed and the driver functioned as intended.The root cause of the reported issue was due to the physical damage of the connectors of the connection 1 receptacle cable and the power adaptor, most likely caused by an impact shock or rough handling.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4773 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: 8610263
• MDR Text Key: 145139016
• Report Number: 3003761017-2019-00109
• Device Sequence Number: 1
• Product Code: LOZ
• 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: 07/22/2019

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 Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 07/23/2019
• Patient Sequence Number: 1
• Patient Age: 28 YR