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

Model Number 595000-001

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

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 cpc (colder products company) connector is a component that provides the interface between the driver drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that patient's right driveline could not detach due to a displaced cpc connector spring.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.

Manufacturer Narrative

The right cpc connector from freedom driver s/n (b)(6) driveline was returned to syncardia for evaluation.Visual inspection confirmed the customer-reported issue of a displaced spring.This failure mode aligns with the failure mode determined in capa- 0266, cpc connector issues.Syncardia has a corrective and preventive action (capa) to address the issue of missing or displaced springs in cpc connectors.From the results of the capa investigation, the primary root cause of spring displacement within the cpc connectors is the use of a wire tie within the cpc connector body (which can come in contact with the spring).Clinicians and patients are trained to thread a wire tie beneath the thumb release tab of the cpc connectors to prevent accidental disconnection of the cannulae from the drivelines.It is possible that a cpc connector spring can be displaced when the wire tie is threaded through, or removed from, the connector during or after a driver switch out.Syncardia capa-0266, cpc connectors, is currently at step 5 action plan.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: 10062400
• MDR Text Key: 204580234
• Report Number: 3003761017-2020-00129
• 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: 07/22/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR