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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, the freedom driver continued to perform its life-sustaining functions.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 customer, a syncardia certified hospital, reported that the freedom driver exhibited a chirping sound (possible intermittent alarm) that progressed into a (permanent) fault alarm while supporting a patient.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

During investigation testing, the customer-reported chirping noise and fault alarm were reproduced.The root cause of the customer-reported fault alarm was determined to be the inability of the piston cylinder assembly (pca) to complete the downward movement.The alarm is produced when the bottom pca sensor does not detect any movement for five seconds.The root cause of the customer-reported noise was determined to be caused by the scotch yoke dowel pin hitting the primary motor cam follower with an increased force, which was evidenced by wear and metallic debris.This issue will continue to be monitored and trended as part of the customer experience process.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: 7292561
• MDR Text Key: 101136390
• Report Number: 3003761017-2018-00067
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

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: 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: 02/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR