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 Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver is also equipped with redundant power sources, including multiple rechargeable freedom onboard batteries and an external battery charger which provide additional means of mitigating the impact to patient care in the event that the power adapter cannot be connected.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 connection 1 receptacle is the connector located on the freedom driver housing that connects the power adaptor to the freedom driver.The customer, a syncardia authorized distributor, reported that the freedom power adaptor plug was damaged at the freedom driver connection 1 receptacle while supporting a patient.The customer also reported that the patient was switched to the backup freedom driver with no adverse patient impact.

Manufacturer Narrative

The customer-reported broken (pushed in) connection 1 receptacle cable was confirmed via visual inspection where it was observed that the external portion of the connector was broken off and the internal portion was lodged internally inside the driver housing.It is unknown how the connection 1 receptacle cable was damaged, but it is likely the result of either the application of excessive force when connecting the power adaptor to the driver, rough handling, or an impact shock to the driver.After a reliable connection was made with the connector on the connection 1 receptacle cable, the driver passed all sections of functional testing.Syncardia has a corrective and preventive action (capa) to investigate the issue of damaged connection 1 receptacle cables.Syncardia has completed its evaluation of this complaint 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: 8713241
• MDR Text Key: 150403981
• Report Number: 3003761017-2019-00201
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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: 06/12/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR