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

Catalog Number 397002-001

Device Problems No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)

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

Event Date 12/14/2022

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported that after the patient returning from trip to radiology, the driver was plugged in and functioning normally when they received several very short emergency battery error and emergency battery low alarms that resolved quickly.It was reported that this was the 2nd occurrence but no data available from first time.Patient was switched to a back-up 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 found no new permanent alarms recorded in the driver's data file.Review of patient data file indicated multiple, short duration alarms lasting between 1 and 13 seconds occurring between (b)(6) 2022 and (b)(6) 2022.Visual inspection of internal and external components revealed no abnormalities.Companion 2 driver passed all incoming functional testing.Additional evaluation and testing was performed on the emergency battery system.No faults or capacity issues were identified.Batteries were subjected to a ten-minute discharge test and performed as intended.Failure investigation for this complaint confirmed the reported issue via patient data file review.The complaint was not replicated via functional testing.The root cause of the customer reported issue was unable to be conclusively determined.When the driver is unplugged the emergency battery will drain over time.Once the driver is plugged back in, alarms due to low battery can occur.The batteries will begin to recharge and the alarms will cease.This is likely what led to the short, intermittent alarms reported by the customer.Failure investigation identified no test failure, damage or abnormalities that could have contributed to the reported alarms.Driver functioned as intended.Patient was switched to the backup driver and no adverse impact reported.Comp(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: 16104234
• MDR Text Key: 306812724
• Report Number: 3003761017-2022-00149
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• 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: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2019
• 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: 39 YR
• Patient Sex: Male