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 Pulmonary Edema (2020)

Event Date 02/12/2023

Event Type  Injury  

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 certified hospital, reported that the driver had a red fault alarm that wouldn't resolve.As the patient was traveling alone, and just previously switched his driver, there was no other driver available to switch to.Ems (emergency medical services) was called and patient transported to (b)(6).Ems noted initial sbp (systolic blood pressure) of 160.It was unknown how long patient had been hypertensive.Patient was subsequently transferred via flight team to (b)(6) on the alarming driver.The (b)(6) team was in contact with syncardia clinical support who met them and the patient, in the icu (intensive care unit) and switched the patient onto a companion 2 driver.Patient was alert and talking in the ed at musc initially, however subsequently developed flash pulmonary edema requiring intubation.

• 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
• MDR Report Key: 16452353
• MDR Text Key: 310337831
• Report Number: 3003761017-2023-00018
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male