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

Catalog Number 595000-001

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

(mcs coord) received a call from patient's caregiver stating that since last night the patients primary freedom driver has had a "galloping/whirring sound." patient felt uneasy about the sound, since it was new.The patient requested that fd be changed to another driver.Patient came into the mcs clinic, and the fd was changed to a new one.The old primary driver will be sent back to syncardia.No alarms or device issues occurred.

Event Description

(mcs coord) received a call from patient's caregiver stating that since last night the patients primary freedom driver has had a "galloping/whirring sound." patient felt uneasy about the sound, since it was new.The patient requested that fd be changed to another driver.Patient came into the mcs clinic, and the fd was changed to a new one.The old primary driver will be sent back to syncardia.No alarms or device issues occurred.

• 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 siverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 17901723
• MDR Text Key: 325847692
• Report Number: 3003761017-2023-00139
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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 Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• 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: 31 YR
• Patient Sex: Female