MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Model Number 397002-001

Device Problem Noise, Audible (3273)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that while supporting a patient, the companion 2 driver exhibited a high-pitched noise, however, there were no alarms displayed on the screen.There was no reported adverse patient impact.The customer also reported the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Device history record (dhr) review confirmed that companion 2 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 no new alarms recorded in driver's data file.Visual inspection of external components found one of the keys was bent within the keyswitch.Visual inspection of internal components found lcd connector cable was partially disconnected when the battery tray was opened.Driver was unable to undergo functional testing for acceptance at incoming inspection as the driver was displaying a blank white screen upon boot up.After lcd connector cable was reconnected, driver still could not be tested due to a blank white screen.Main board was replaced with a known functional board and resulted in driver passing all areas of functional testing.The original main board was then re-installed and re-programmed resulting driver booting up properly and passing all areas of functional testing.An observation run was performed with no alarms or abnormalities produced.Failure investigation for this complaint could not confirm the reported issue.The specific customer complaint was not replicated during testing; root cause of the reported high-pitched noise was unable to be determined.A malfunction with the main board was found during investigation, however, it was unrelated to the reported complaint.Failure investigation identified no other test failures or damage that could have contributed to the complaint.The bent key on the driver will be rejected and replaced, however, it did not contribute to the complaint.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 customer, a syncardia certified hospital, reported that while supporting a patient, the companion 2 driver exhibited a high-pitched noise, however, there were no alarms displayed on the screen.There was no reported adverse patient impact.The customer also reported the patient was subsequently switched to a backup driver.

• Brand Name: SYNCARDIA COMPANION 2 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: 12409208
• MDR Text Key: 280603172
• Report Number: 3003761017-2021-00166
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• 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: 41 YR
• Patient Sex: Male