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

Catalog Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer, a syncardia authorize distributor, reported that the patient's hospital standby freedom driver exhibited a fault alarm upon start-up.The freedom driver was not supporting a patient at the time of the event.

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 one new alarm indicating secondary motor engagement recorded in the driver's data file.However, as the secondary motor was found in the default position, there is no evidence secondary motor engagement occurred.The fault alarm was likely produced at syncardia during the investigation.Visual inspection of external components found no abnormalities.Visual inspection of internal components found no abnormalities.Freedom driver passed all functional testing for acceptance at incoming inspection.Additional testing was performed in an attempt to replicate the customer reported fault alarm.A power cycle test was performed, no alarms were produced.Customer complaint could not be replicated.The freedom driver passed all functional testing at incoming inspection and during investigation testing.Complaint could not be replicated.The failure investigation found no evidence of a device malfunction.Device was not in use by a patient 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 customer, a syncardia authorize distributor reported that the patient's hospital standby freedom driver exhibited a fault alarm upon start-up.The freedom driver was not supporting a patient at the time of the event.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DEVICE
• 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: 15723760
• MDR Text Key: 305088258
• Report Number: 3003761017-2022-00121
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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: 10/25/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/30/2022
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2017
• 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: 30 YR
• Patient Sex: Male