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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

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, the freedom driver continued to perform its life-sustaining functions.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) freedom driver s/n (b)(4) (mfr report # 3003761017-2019-00156) and (2) freedom driver s/n (b)(4) (mfr report # 3003761017-2019-00157).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 the red cpc connector on freedom driver s/n (b)(4) had an air leak while supporting a patient.The patient was switched to a back-up driver.The customer, a syncardia certified hospital, also reported that the blue cpc connector on freedom driver s/n (b)(4) had an air leak while supporting a patient.The patient was switched to a back-up driver.There was no reported adverse patient impact.

Manufacturer Narrative

The customer-reported air leak was not able to be confirmed or reproduced with the freedom driver and its drivelines.The freedom driver passed all sections of functional testing.Additionally, an air leak test was performed on the drivelines, including the cpc connectors, and no leaks were observed.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: 8621135
• MDR Text Key: 145547565
• Report Number: 3003761017-2019-00156
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• 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: 05/03/2019
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR