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

Model Number 397002-001

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited a system malfunction alarm while supporting a patient.The patient was switched to a backup driver and there was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of external components found no evidence of damage or abnormalities.Visual inspection of internal components found cosmetic damage to two capacitors on the power management board.The damaged capacitors is unrelated to the customer reported issue.The driver passed all incoming functional testing.Review of patient data file confirmed the system malfunction alarm.Additional operational testing could not replicate the alarm; however, based upon alarm data review, the alarm recorded as a result of the driver key switch operation while in use.To troubleshoot, the key switch was turned approximately one quarter of the way to the off position and released which returned it to the on position.This test replicated the system malfunction alarm.Because it is unknown if the key was left in the key switch while the driver was in operation, it is not possible to confirm the root cause of the customer reported issue of a system malfunction alarm.However, the root cause, based upon patient data file review, is most likely an unintended rotation of the key in the key switch while the driver was in use.Product labeling instructs the user to remove the key and store it in a designated location during operation to prevent the driver from being turned off while in use.Investigation found no evidence of a device malfunction.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: 10503239
• MDR Text Key: 207529047
• Report Number: 3003761017-2020-00186
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2020
• 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: 31 YR
• Patient Sex: Male