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

Model Number 397002-001

Device Problems Device Displays Incorrect Message (2591); Audible Prompt/Feedback Problem (4020)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited right overpressure alarms, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver has been returned to syncardia for evaluation.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 right overpressure alarms anytime it was disconnected from wall air while supporting a patient.The customer also reported that the companion 2 driver generated an emergency battery alarm while connected to ac and both external batteries attached.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.

Manufacturer Narrative

The driver's patient data file and alarm history was reviewed and revealed 51 right overpressure alarms and two emergency battery-related alarms.The emergency battery in use alarm was recorded prior to the connection to the patient, likely during the system checkout.One emergency battery low alarm was observed to be recorded for one second; the cause of this alarm cannot be determined.The reported right overpressure and emergency battery alarms were not able to be reproduced.During investigation testing, the driver functioned as intended and passed all requirements.Additionally, the emergency battery was independently tested and found to function as intended and met all specifications.The root cause of the customer-reported alarms could not be conclusively determined.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation 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: 7358323
• MDR Text Key: 103422208
• Report Number: 3003761017-2018-00086
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

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 Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR