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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

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.(b)(4).

Event Description

The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver did not pass the system check out.

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 two new alarms, indicating secondary motor voltage too high and speaker 2 voltage too high when on, recorded in driver's data file.Visual inspection of external components found cosmetic damage to the display window and the display and fan covers.Visual inspection of internal components found top left anchor boss pulled out and top righa and bottom left anchor boss cracked.Scuffs were found within in the piston cylinder assembly as well as a melt mark on the ribbon cable that runs from the speaker to lcd near primary motor.Freedom driver passed all areas of functional testing for acceptance at incoming inspection.Additional testing included an extended observation run and separate testing of the secondary motor system to determine functionality.No alarms or malfunctions were observed.Primary and secondary motors were found to spin by hand freely.Complaint could not be replicated.Failure investigation for this complaint confirmed the reported issue.The customer complaint was not replicated during testing; root cause of the unresolvable red alarm was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.Cracks and scuffs found internally and externally are cosmetic only.No device malfunction found.Device was not in patient use at time of complaint.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 freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver did not pass the system check out.

• 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: 12771397
• MDR Text Key: 281417245
• Report Number: 3003761017-2021-00212
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• 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