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

Catalog Number 595000-001

Device Problems Insufficient Information (3190); Audible Prompt/Feedback Problem (4020)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

Freedom driver s/n (b)(6) returned to syncardia for investigation.Results will be provided in a follow-up mdr.

Event Description

Mcs coordinator was called about a continuous fault alarm for patient, 21-lr.Blood pressure was within normal limits, but fill volumes and cardiac outputs were low.Patient was removed from freedom driver, sn (b)(6), and placed on companion 2 driver switch with done without incident and settings were adjusted to maintain adequate cardiac output.We are not sure if this is a patient issue or a driver issue, but would feel more comfortable placing the patient on a different freedom driver when she is ready.

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 indicating left driver pressure was too low for long enough to cause a permanent time-out.This has historically been produced as a result of the driver running while disconnected from the patient.Visual inspection of external components found crack in the display and fan covers as well as damage to the front housing on the edge where the onboard batteries are inserted.Visual inspection of internal components found no abnormalities.Freedom driver passed all areas of functional testing for acceptance at incoming inspection.A 48-hour observation run was performed to monitor cardiac output values and acknowledge any unresolvable fault alarm, per complaint.Although an error with the investigation occurred as the mock tank chamber had a leak, once repaired the driver functioned normally without alarm or cardiac output issues.Complaint could not be replicated.Failure investigation for this complaint confirmed the reported issue from data file review.The customer complaint was not replicated; the root cause of the reported out of specification output values and fault alarm was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.Damage found to external components of the driver were cosmetic only.No evidence of a device malfunction was found.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

Mcs coordinator was called about a continuous fault alarm for patient, 21-lr.Blood pressure was within normal limits, but fill volumes and cardiac outputs were low.Patient was removed from freedom driver, sn (b)(6), and placed on companion 2 driver switch with done without incident and settings were adjusted to maintain adequate cardiac output.We are not sure if this is a patient issue or a driver issue, but would feel more comfortable placing the patient on a different freedom driver when she is ready.

• 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: 17896629
• MDR Text Key: 325378666
• Report Number: 3003761017-2023-00124
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 21 YR
• Patient Sex: Female