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

Catalog Number 397002-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver is being evaluated by syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine evaluation, a syncardia technician reported that the companion 2 driver did not pass the system check procedure.

Manufacturer Narrative

Review of the patient data file revealed that the driver did not pass any system check steps associated with right pressure.During functional testing of the driver, the reported issue was reproduced as the driver did not pass the system check step.Investigation testing determined the root cause to be a malfunction of the pressure sensor board.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(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
• MDR Report Key: 9362445
• MDR Text Key: 167764869
• Report Number: 3003761017-2019-00340
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 000858000003107
• UDI-Public: (01)000858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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: Other
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1