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

Catalog Number 397002-001

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005); Audible Prompt/Feedback Problem (4020)

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

Event Date 03/27/2023

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

A syncardia clinical support employee, was on-site at a syncardia certified hospital location, observed the driver not showing left side flow on the waveform display, and the driver had a low cardiac output alarm.The driver was not supporting a patient at the time of the event.

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 left pressure issues while driver was at customer site.Additionally, it was noted there was no left flow waveform and there was low left cardiac output.Visual inspection of external and internal components found no abnormalities.Driver failed incoming inspection for out of specification cardiac output and loss of left waveform.Additional testing included moving the left mass airflow sensor cable around, resulting in fluctuating cardiac output as well as swapping the left cable with the right, resulting in loss of cardiac output on the right side.A known, functional cable was installed on the left side resulting in normal cardiac output.The driver passed four system checks all areas of functional testing with replacement left mass airflow sensor cable.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated; root cause of the loss of left waveform and low cardiac output was determined to be a faulty mass airflow sensor cable assembly.Failure investigation identified no other test failures or damage that could have contributed to the reported complaint.The device was not in patient use at time of complaint.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

A syncardia clinical support employee was on-site at a syncardia certified hospital, and reported that the driver powered on, and had no left side flow waveform and a low cardiac output alarm.

• 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: 16743362
• MDR Text Key: 313326138
• Report Number: 3003761017-2023-00049
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2019
• 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