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

Catalog Number 397002-001

Device Problem Battery Problem (2885)

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

Event Date 11/23/2022

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

In order to prepare the implantation of the patient hl in la pitié on (b)(6) 2022, the staff wanted to test the companion.But, the internal battery of the companion driver went into alarm and its light remained on, while the driver was permanently plugged in.This incident is confirmed at stc office.

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 four emergency battery error alarms.Visual inspection of external components found no abnormalities.Visual inspection of internal components found damage on power management board.Companion 2 driver failed functional testing at incoming inspection due to an emergency battery alarm and the inability of emergency battery to power driver.An additional test of the emergency battery was performed and data review found absolute state of charge and full charge capacity our of specification, confirming customer report.Emergency battery was replaced in driver; all subsequent functional testing passed.Failure investigation for this complaint confirmed the reported issue.Test data review confirmed emergency battery was not functional, replicating customer complaint; root cause is determined to be malfunctioning emergency battery.Failure investigation identified no other test failures that could have contributed to the complaint.Damage found on capacitor on the power management board did not contribute to customer complaint.Device was not in 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

In order to prepare the implantation of the patient (b)(6) in la pitié on (b)(6) 2022, the staff wanted to test the companion.But, the internal battery of the companion driver went into alarm and its light remained on, while the driver was permanently plugged in.This incident is confirmed at stc office.

• 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: 15966341
• MDR Text Key: 308117314
• Report Number: 3003761017-2022-00134
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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