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

Model Number 595000-001

Device Problems Mechanical Jam (2983); Material Split, Cut or Torn (4008); Audible Prompt/Feedback Problem (4020)

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

Event Date 02/15/2021

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 (b)(4).

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 kneeling down, stood up quickly, got lightheaded and 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 review found one new permanent alarm recorded in the driver's eeprom.This fault alarm code can occur during servicing or as a result of secondary motor engagement.Alarm record confirmed the customer reported issue.Visual inspection of external components found a missing foot on the front, right side of the driver, abrasions on the strap loop, and cracked housing bosses on both the left and right front housing.Visual inspection of internal components found the secondary motor was out of default position, confirming secondary motor engagement.The scotch yoke in the piston and cylinder assembly (pca) was broken along top right, such that secondary motor would be unable to actuate the piston action of the pca.Scuff marks found on the pca and main pcb that indicate contact between the components.The ribbon cable which connects the speaker to the lcd was found to have a melt mark on the side where the bend is closest to the primary motor.The driver failed incoming functional testing for cardiac output as a result of the damage to the pca and right speaker volume below specification due to cable damage.The customer reported fault alarm was confirmed through alarm history data review, which revealed the presence of a permanent alarm that can occur as a result of secondary motor activation, and visual inspection of internal components which found the secondary motor out of default position.The root cause of the permanent fault alarm was secondary motor engagement, which most likely caused the damage to the scotch yoke observed during visual inspection.Syncardia has create a corrective and preventive action (capa), freedom driver pca fractured scotch yokes, to further investigate the issue.Damage to both external and internal components observed during the investigation are indicative of rough handling.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.Ce 5485 (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: 11349079
• MDR Text Key: 232598054
• Report Number: 3003761017-2021-00028
• 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: 02/19/2021
• 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: 02/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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: 32 YR
• Patient Sex: Male