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

Model Number 595000-001

Device Problems Crack (1135); Mechanical Problem (1384); Mechanical Jam (2983); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce 5496 initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting the patient.The patient stated he was just lying in bed going to sleep when the alarm began.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Alarm history data review found one new permanent alarm recorded in the driver's alarm history.This alarm is produced as a result of a sensor in the pca not detecting movement for at least 4 seconds, which causes the secondary motor to engage in order to keep the device pumping.Visual inspection of the driver's external components found cracks in the display cover around the display window.Damage is cosmetic and did not impact the functionality of the driver.The display cover will be replaced during service.Visual inspection of internal components found a crack in the top of the scotch yoke, and particulate/debris on the interior of the driver housing, on top of the motors and pca, and on the underside of the ribbon cable that connects the speaker to the lcd.The primary motor was found to be inoperable and could not be manually turned.Front cover housing bosses were cracked at the upper right corner and on both the left and right lower corners.Scuff marks were found on the main pcb and on the pca indicating contact.Scratch marks were visible near the mount screws on the frame bracket assembly on the front side of the driver.Melt marks were found on the ribbon cable at location near primary motor.The primary motor was replaced in order to perform functional testing.At startup, the driver made a cracking sound and stopped pumping within seconds.Subsequent internal inspection showed that the top of the scotch yoke had broken off where it was was previously cracked.This piece of broken scotch yoke became lodged in the pca and prevented movement of the piston.The complaint was confirmed upon examination of the drivers alarm history data, which revealed a new alarm indicating a sensor in the pca did not detect movement for at least 4 seconds.When this occurs, the secondary motor will automatically engage in order to keep the device pumping.The complaint was replicated during incoming functional test, which it failed because a permanent alarm started shortly after beginning the test.The root cause of the permanent fault alarm was the driver switching to operation on the secondary motor as a result of the binding/faulty primary motor.From the investigation, it was discovered the primary motor was bound and no longer rotating.When the driver switches to secondary motor operation, it is designed to alarm to alert the user to exchange the driver.Motor binding is a known issue being investigated per freedom driver motor failures capa.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 11477520
• MDR Text Key: 247686226
• Report Number: 3003761017-2021-00037
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Male