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

Model Number 397002-001

Device Problems Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Audible Prompt/Feedback Problem (4020)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine evaluation, a syncardia technician reported that the companion 2 driver did not pass the system check.

Manufacturer Narrative

Review of the patient file confirmed ystem check failure on 16 dec 2020 that aligns with the test failure.While in the field, two system checks were performed with passing results followed by three system checks, which did not pass.These failed system checks were never reported to syncardia.Visual inspection of the driver's external components found cosmetic damage (scratch) on the touchscreen.The damage did not affect the driver's functionality.Visual inspection of the driver's internal components found the right driveline tubing was kinked.A kink in this tubing would affect the flow on the right side, resulting in the right-side flow failure and the low cardiac output failures observed during incoming testing.The kinked tubing was removed from the driver and measured to confirm it met length specification requirements.The tubing was confirmed to meet specification requirements for length and was most likely kinked when the driver display was installed.The incoming test failure was confirmed upon examination of the patient file, which revealed a system check failure on the date of the complaint.The incoming test failure was replicated during functional testing, where the issue had occurred with additional failures relating to low cardiac output.The root cause of the test failure is a kinked internal driveline tube.The kinked tubing was causing a restriction of airflow through the right driveline, resulting in the failed system check as well as the failures due to low cardiac output of the functional test.The driver failed incoming functional testing when it was returned for two-year service.The driver was not in patient use.Previous system check failures occurring in the field were not reported to syncardia.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: 11150485
• MDR Text Key: 226316041
• Report Number: 3003761017-2021-00001
• 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: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• 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