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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Audible Prompt/Feedback Problem (4020)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2020

Event Type  malfunction  

Manufacturer Narrative

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) initial.

Event Description

The customer, at syncardia hospital, reported that the freedom driver exhibited a temperature alarm while supporting the patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.

Manufacturer Narrative

Visual inspection of the internal and external components of the driver revealed housing separation, dust on the fan and fan cover, the secondary motor out of bottom dead center (bdc) position, and the primary motor was difficult to rotate by hand.The driver's alarm history was reviewed and revealed two alarms, 2d and 2f, that would have been experienced by the customer.There was no temperature alarm in the alarm history as the temperature alarm will only become permanent if it persists for longer than thirty minutes.The 2d alarm can be produced during the manufacturing / servicing process or produced as a result of the operation of the secondary motor.Since the secondary motor was observed to be out of the bdc position, it is likely that it was produced because of secondary motor engagement.The 2f alarm can be produced as a result of increased resistance on the primary motor circuit, or from the external power supply having inadequate voltage supply, or if system current is greater than 4 ± 0.25 amp.The evidence of the primary motor being difficult to rotate may have led to the 2f alarm.The driver did not pass functional testing as it exhibited a continuous alarm.Due to evidence of secondary motor engagement and difficulty turning primary motor, the functional test was redone with a test primary motor installed.The driver passed the test with the test motor.Although no temperature alarm was reproduced, it is likely that the malfunctioning primary motor generated enough heat for the driver to feel hot to the touch.The root cause of the customer-reported issue of a temperature alarm was determined to be a malfunction of the primary motor.Syncardia has a corrective and preventative action (capa) for the issue of motor binding.Syncardia has completed its investigation 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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10477291
• MDR Text Key: 214799339
• Report Number: 3003761017-2020-00185
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 08/24/2020
• 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: 56 YR
• Patient Sex: Male