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 02/20/2023

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver did not recognize the external batteries during system checkout.Batteries were removed and replaced with several other batteries which the companion 2 driver also did not recognize.The customer also reported that the power cord icon did not display on the screen.The customer also reported that the companion 2 driver did operate on the emergency battery when removed from the hospital cart, and when the companion 2 driver was placed back into the hospital cart and the power was cycled on and off, the problems did not resolve.

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

The customer, a syncardia certified hospital, reported that the companion 2 driver did not recognize the external batteries during system checkout.Batteries were removed and replaced with several other batteries which the companion 2 driver also did not recognize.The customer also reported that the power cord icon did not display on the screen.The customer also reported that the companion 2 driver did operate on the emergency battery when removed from the hospital cart, and when the companion 2 driver was placed back into the hospital cart and the power was cycled on and off, the problems did not resolve.

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 no alarms in driver's data file.Visual inspection of external and internal components found no abnormalities.Driver passed all areas of functional testing for acceptance at incoming inspection.Additional testing included external battery and a/c power testing using ten known functional batteries.Driver recognized both external battery and a/c power, was able to charge batteries and operate freely from the external batteries.Complaint could not be replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint could not be replicated; the root cause of the reported companion 2 driver's inability to recognize external batteries was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.No evidence of a device malfunction was found.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.

• 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: 16495603
• MDR Text Key: 310797568
• Report Number: 3003761017-2023-00022
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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 Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2018
• 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