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

Catalog Number P/N 397002-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Audible Prompt/Feedback Problem (4020)

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

Event Date 03/23/2023

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.

Event Description

The customer, a syncardia certified hospital, reported that the driver arrived sounding a high pitched continuous alarm while inside the pelican case it was shipped in.

Manufacturer Narrative

Alarm history and patient data file review found two new faults alarms: one system malfunction and one computer malfunction.The system malfunction alarm can occur when there is a communication issue between the left and right embedded supervisors, such as, when the key is bumped and only one supervisor receives the shut down command.The computer malfunction alarm occurs when there is a sudden loss of communication such as driver shutting down from lack of a power source.Visual inspection of internal and external components revealed no abnormalities.The companion 2 driver failed incoming functional testing for system check related to 9v battery voltage.Additional testing was performed where the 9v battery was replaced and system check retested which then passed.The 9v battery failure during system check is not the cause of continuous alarm as reported by the customer as the alarm sounding is what depleted the 9v battery as it supplies voltage to buzzer.Failure investigation for this complaint confirmed the reported issue via alarm history data review and functional testing.The complaint was not replicated via functional testing.The root cause of the driver alarming upon arrival at the user facility was unintentional powering on of the driver as a result of the key being bumped during shipping/handling.In transit, the only power source installed is the 9v emergency internal battery.The companion 2 driver is not intended to power on during shipment and the driver was not usable by the customer at the time of receipt as the 9v battery was drained as a result of the constant alarm during shipping.Quality issues with the companion 2 keys during shipping are a known issue being addressed in capa-2022-0009.Failure investigation identified no test failure, damage, or abnormalities that could have contributed to the customer reported issue.Driver functioned as designed and there was no patient involvement.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.) (b)(4) follow-up report 1.

• 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: 16743359
• MDR Text Key: 313807158
• Report Number: 3003761017-2023-00046
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P/N 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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