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

Model Number 595000-001

Device Problems Corroded (1131); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.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 freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver had a corroded cpc connector.

Manufacturer Narrative

Visual inspection of the driver's driveline found notable deterioration and discoloration on the metal of the cpc connector.The discolored section of metal could not be wiped off the cpc connector.These findings are consistent with corrosion of metal.The driver in "as received" condition passed all sections of functional testing.The customer-reported issue was confirmed during the investigation; however, the root cause of the corrosion damage on the cpc connector could not be conclusively determined.It is possible that the corrosion was caused by fluid getting on the cpc connector.F-900012-en, freedom driver system operator manual, section 4.2 states "do not submerge the freedom driver system or expose it to liquid/debris.Protect it from rain, showers, baths, and liquid/debris." if a driver is exposed to liquid, f-900012-en states that the driver must be exchanged for a backup freedom driver.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.(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: 9214166
• MDR Text Key: 163064115
• Report Number: 3003761017-2019-00306
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: 10/16/2019
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1