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

Model Number 595000-001

Device Problems No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)

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

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

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) initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a low battery alarm while supporting the patient.The hospital plugged the freedom driver into wall power and while exchanging the onboard batteries, the driver exhibited a permanent fault alarm.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.

Manufacturer Narrative

The driver's alarm history was reviewed and revealed two fault codes, 1e and 49.The 1e code, mpu regulator 1 too low, can occur because of a change in voltage during an onboard battery exchange.Voltage fluctuations during battery exchanges are normal; however, on an infrequent basis, the freedom driver will detect the voltage fluctuations as an issue resulting in a fault alarm.The 49 code, cardiac output too low for long enough to be permanent, can occur due to the kinking of the driveline, or due to patient hypertension or hypervolemia.The driver passed all sections of functional testing as well as a 48-hour observation test.Since the 1e fault code was observed in the alarm history, a battery exchange test was performed.No alarms were produced during this test.Two freedom hospital ac power supplies were also returned with the driver and tested per freedom hospital ac power supply evaluation shop order.Visual inspection confirmed missing rubber feet but no damage to the connectors.During investigation testing, the customer-reported issue of a low battery alarm followed by a permanent fault alarm were not reproduced.The root cause of the customer-reported low battery alarm and permanent fault alarm could not be conclusively be determined.The driver performed as intended with no evidence of a device malfunction.This issue will be tracked and trended as part of the customer complaint process.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: 10197691
• MDR Text Key: 207529482
• Report Number: 3003761017-2020-00142
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

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: 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: 06/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• 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: 47 YR
• Patient Sex: Female