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); Audible Prompt/Feedback Problem (4020)

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

Event Date 07/16/2023

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported a continuous fault alarm after patient had a vomiting event.Freedom driver could be heard fault alarming over the phone.Patient's bp was within normal limits and fill volumes and cos were adequate.Patient was switched to a back up driver without any reporting of adverse impact.

Manufacturer Narrative

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

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom driver s/n 5031a 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, fault codes 2f indicating system current is too high and 2d indicating secondary motor voltage is too high.Visual inspection of external components found display cover and fan cover cracked/damaged.Visual inspection of internal components found secondary motor out of alignment, indicating secondary motor engagement.Freedom driver passed all functional testing for acceptance at incoming inspection.An additional test was performed to replicate the conditions during the patient's vomiting episode.A valsalva test was performed with manipulations to the mock tank; tank levels were visibly disturbed and driver exhibited a recoverable alarm, as designed.Customer complaint could not be replicated.Failure investigation for this complaint confirmed the reported issue from the extracted alarm data.The complaint was not replicated during testing; the root cause of the continuous alarm after patient's vomiting episode could not be determined.Failure investigation identified no test failure or damage that could have contributed to the complaint.Damage found to the fan and display covers was cosmetic only.Freedom driver functioned as designed.Patient was switched to a backup driver without any reported adverse impact.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 certified hospital, reported a continuous fault alarm after patient had a vomiting event.Freedom driver could be heard fault alarming over the phone.Patient's bp was within normal limits and fill volumes and cos were adequate.Patient was switched to a back up driver without any reporting of adverse impact.

• 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: 17371690
• MDR Text Key: 319862778
• Report Number: 3003761017-2023-00105
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 07/16/2023
• Supplement Dates FDA Received: 01/12/2024
• 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: 33 YR
• Patient Sex: Male