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

Catalog Number 397002-001

Device Problem Noise, Audible (3273)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited an unusual noise while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

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

Manufacturer Narrative

Alarm history review reported the patient file was reviewed; no alarms were found present in the file.No external abnormalities observed during external inspection.No internal abnormalities observed during internal inspection.The driver passed incoming inspection and final assembly functional test.During this test no "funny noise" was observed from the driver.In an attempt to reproduce the noise observed by the customer, the driver was setup for an observation run.This observation run lasted approximately 96 hours.During this observation run no abnormal noise, alarms, or anomalies were observed.Failure investigation could neither confirm nor replicate the customer reported "funny, squeaking" noise.No damage or abnormalities were observed.Driver passed all functional testing including observation run testing.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: 15725836
• MDR Text Key: 304967585
• Report Number: 3003761017-2022-00122
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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
• Patient Age: 16 YR
• Patient Sex: Female