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

Catalog 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 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a system malfunction alarm, it continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited a system malfunction alarm while supporting a patient.The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.

Manufacturer Narrative

The customer-reported system malfunction alarm and failed system check were confirmed upon review of the driver's alarm history and patient file data and were reproduced during investigation testing.The system malfunction alarm was likely caused by the companion drivelines being disconnected from the driver during operation, and is not indicative of a device malfunction.Further investigation and testing determined the root cause of the system check failure to be a malfunction of the left compressor.Evaluation of the left compressor revealed that the counterweight was grinding against the inside of the end cap.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: EXTERMAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7121654
• MDR Text Key: 95904811
• Report Number: 3003761017-2017-00253
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• 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 Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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: 47 YR