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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

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.

Event Description

The customer, a syncardia authorized distributor, reported that the patient experienced a "red alarm" and the display showed "asterisks and bpm (beats per minute)." the patient switched to a back-up driver.There was no reported adverse patient impact.

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 no new alarms recorded on driver's data file.Visual inspection of external components found light crimp/crease marks on drivelines.Visual inspection of internal components found no abnormalities.Freedom driver passed all functional testing for acceptance at incoming inspection.An additional 48-hour observational test was performed but no red alarm or asterisks on driver display were produced.Complaint was not replicated, however, after the first 15 minutes of operation, a kink on the drivelines would produce a recoverable alarm and asterisks on the driver display but this occurrence cannot be confirmed.Failure investigation for this complaint could not confirm the reported issue, however, it is known that a kink in the driveline could result in a recoverable alarm and asterisks on the driver display.The customer complaint was not replicated; the root cause of the customer reported complaint was unable to be determined.Failure investigation identified no test failures or other damage that could have contributed to the complaint.The visual inspection of the drivelines shows a kink/crease that likely would have resulted in a recoverable alarm, however, this is not a malfunction.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 patient experienced a "red alarm" and the display showed "asterisks and bpm (beats per minute)." the patient switched to a back-up driver.There was no reported adverse patient impact.

• 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: 16743360
• MDR Text Key: 313721508
• Report Number: 3003761017-2023-00045
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• 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: 61 YR
• Patient Sex: Male