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

Model Number 397002-001

Device Problems Mechanical Problem (1384); Material Deformation (2976); Audible Prompt/Feedback Problem (4020)

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

Event Date 06/10/2021

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.Ce (b)(4).

Event Description

The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited a single compressor malfunction alarm while supporting a patient during her chemotherapy treatment.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Patient file review showed that the driver was put on patient support and ran with no issues until the date of the event when a single compressor malfunction alarm was observed.Visual inspection of external components found no evidence of damage or abnormalities.Visual inspection of internal components found two dented capacitors on the power management board.This is a known cosmetic issue, and syncardia has a corrective and preventive action (capa) for the issue of companion 2 driver power management board component failures.Damage is unrelated to the single compressor malfunction alarm.The driver failed incoming functional system check test but no compressor malfunction alarm occurred.A 48 hour observation run was set up using the settings recorded in the patient file; no alarms were observed.The compressor was removed for closer inspection.End cap was removed to see if there was any debris or damage to counter weight or inside end cap in motor that could have contributed to a single compressor alarm.No signs of damage or debris could be found.Next, evaluation was performed to determine the cause of the system check failure at incoming.Patient file review determined the test failure was due to the driver failing both right zero flow tests.Because of this, the mass flow sensor cable was suspected to be faulty.The mass flow sensor cable was replaced with a known functional test cable and the system check test was performed again, this time with passing results.Patient data file review verified a single compressor malfunction alarm occurred, confirming the customer reported issue.Investigation and testing was unable to replicate the alarm.The investigation for companion 2 driver s/n (b)(6) found no evidence of a device malfunction related to the customer reported issue.No component was identified as the root cause of the single compressor malfunction alarm reported by the customer.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: 12020997
• MDR Text Key: 261549828
• Report Number: 3003761017-2021-00119
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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
• Date Manufacturer Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2018
• 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: 44 YR
• Patient Sex: Female