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

Catalog Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem Hypervolemia (2664)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

The customer, a syncardia authorized distributor, reported that the freedom driver exhibited a fault alarm while supporting the patient at the rehabilitation center.The patient¿s blood pressure was normal and he was sitting down at the time.There was no reported adverse patient impact and the patient was subsequently switched to a backup driver.The customer suspected a patient condition of hypervolemia (fluid overload).The customer subsequently reported that the patient was volume overloaded and was treated with furosemide.

Manufacturer Narrative

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

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found one new alarm recorded in driver's data file.Fault code found due to right drive pressure being too low for long enough that driver permanently timed-out; indicates driver likely running while disconnected from patient.Visual inspection of external components found no abnormalities.Visual inspection of internal components found no abnormalities.Freedom driver passed all functional testing for acceptance at incoming inspection.Additional testing included a disconnection test performed by disconnecting the driver's right driveline from the tank after 15 minutes of operation.A fault alarm annunciated after approximately 3 seconds and was left on for over 30 seconds.The driveline was reconnected but the alarm did not recover.New fault code found recorded in driver's data file confirming a disconnected driveline results in an unresolvable alarm.Additional testing included a hypervolemia test performed by gradually raising rap chamber within and outside functional values to mimic fluid overloaded patient.No alarms resulted and no malfunctions observed.Failure investigation for this complaint could not confirm the reported issue.The complaint was not replicated during testing; the root cause of the unresolvable fault alarm and beat rate drop was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.Freedom driver functioned as designed.Patient was switched to a backup driver without any reported adverse impact.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.

Event Description

The customer, a syncardia authorized distributor, reported that the freedom driver exhibited a fault alarm while supporting the patient at the rehabilitation center.The patient's blood pressure was normal and he was sitting down at the time.There was no reported adverse patient impact and the patient was subsequently switched to a backup driver.The customer suspected a patient condition of hypervolemia (fluid overload).The customer subsequently reported that the patient was volume overloaded and was treated with furosemide.

• 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: 15651988
• MDR Text Key: 302405293
• Report Number: 3003761017-2022-00112
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2017
• 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: 44 YR
• Patient Sex: Male