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

Catalog Number 595000-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

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

Event Date 01/03/2023

Event Type  malfunction  

Event Description

The customer, a syncardia service technician, reported the driver failed the left peak pressure test during incoming.

Manufacturer Narrative

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

Manufacturer Narrative

Alarm history and patient data file review found one new alarm recorded in the driver's eeprom: "2d, secondary motor voltage too high".This alarm was produced at syncardia during eeprom extraction.No alarms were recorded related to the current complaint.Visual inspection of internal components revealed no abnormalities.Visual inspection of external components revealed a broken display cover and broken fan cover.Freedom driver failed incoming functional testing for left peak pressure test.Failure investigation for this complaint confirmed the reported issue via patient data file.The complaint could not be replicated via functional/ observational testing.The root cause of the customer reported complaint could not be conclusively determined.No device malfunction nor component failure was identified.Failure investigation identified no test failure, damage, or abnormalities that could have contributed to the customer reported issue.Driver functioned as designed.No patient involvement is related to this routine service related 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.) (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 85713
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16224410
• MDR Text Key: 307947023
• Report Number: 3003761017-2023-00001
• Device Sequence Number: 1
• Product Code: LOZ
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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 Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2018
• 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