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

Catalog Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

The patient had red alarm.He was sitting and all parameters were normal.Patient switched to backup driver, no adverse reaction reported.

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom driver s/n 5236 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, indicating system current too high and secondary motor voltage too high.Visual inspection of external components found no abnormalities.Visual inspection of internal components found excessive metallic debris on the pca and primary motor, the secondary motor was out of primary alignment, and a grinding noise was observed when primary motor was powered on.The primary motor was found to not spin freely by hand.Freedom driver passed all areas of functional testing for acceptance at incoming inspection.A grinding noise from the primary motor was observed but did not affect the functionality of the driver.An additional 48-hour observation run was performed.The primary motor was observed to again produce a grinding noise and exhibited labored operation but no alarm or malfunction was produced.A test of the driver's secondary motor system was performed due to evidence of secondary motor engagement.Motor passed all functional testing and would reliably provide life support to the patient.Failure investigation for this complaint confirmed the reported issue through alarm data review.The customer complaint was not replicated during testing; the root cause of the reported red alarm was unable to be determined.Failure investigation identified a grinding noise and some debris in the primary motor that may have contributed to the driver activating the secondary motor system and the related alarm.While unintended secondary motor engagement is a known issue that is currently under investigation, it is not a device failure.Primary motor will therefore be dispositioned as a preventative measure.Both motors functioned normally and no evidence of a device malfunction was found.Patient was switched to a backup driver with no 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 patient had red alarm.He was sitting and all parameters were normal.Patient switched to backup driver, no adverse reaction reported.

• 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: 18088791
• MDR Text Key: 328139063
• Report Number: 3003761017-2023-00157
• Device Sequence Number: 1
• Product Code: LOZ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2023

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?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 42 YR
• Patient Sex: Male