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

Model Number 397002-001

Device Problems Incorrect Or Inadequate Test Results (2456); Audible Prompt/Feedback Problem (4020)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2018

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 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 companion 2 driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that the companion 2 driver did not pass the system check procedure.

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) companion 2 10179 (mfr report # 3003761017-2018-00025, (2) companion caddy s/n (b)(6) (mfr report # 3003761017-2018-00487).The companion 2 driver and companion caddy were not in use by a patient.The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable patients while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer, a syncardia authorized distributor, reported that the companion 2 driver was docked in a caddy (mfr.Report # 3003761017-2018-00487) when it did not pass the system checkout procedure.The emergency battery and external batteries could not be charged in the driver.The external batteries could be charged in another driver without issues.The caddy would power the driver when plugged in.The customer also reported that the driver gave several other alarms: like computer malfunction and double compressor malfunction (although pumping) and one time gave a peep only / another time would stop and go off without any reason / have a white screen.

Manufacturer Narrative

The customer-reported issue of the emergency battery and external batteries not being charged by the driver was confirmed, and was determined to be caused by the loose pins of the recognition cable in the receptacle housing (docking connector) of the caddy (mfr report # 3003761017-2018-00487) and not the companion 2 driver.This led to an intermittent connection at the caddy's docking connector between the caddy and the docked companion 2 driver.During this investigation, it was observed that the pins would not stay engaged in the docking connection, resulting in a lack of power to the driver.This lack of power could lead to the driver not charging the batteries (no external power going to the driver).This could also lead to a sudden loss of driver power, which would record a computer malfunction alarm.A sudden loss of driver power/communication will lead to an internal audible alarm - this was most likely the audible noise accompanying the driver power off reported by the customer.The customer-reported computer malfunction and dual compressor malfunction alarms were confirmed upon review of the driver's alarm history but were not able to be reproduced in full during investigation testing.A review of the patient data file also revealed a single compressor malfunction alarm.The observed single compressor malfunction alarm was determined to be caused by the right compressor, which was observed to have its counterweight grinding on the inside of the end cap.The customer-reported dual compressor malfunction alarm was confirmed through review of the patient file.The parameters observed during these alarms are indicative of the driver being in single pulse mode.A single compressor malfunction alarm was observed when the driver was running with the drivelines disconnected from the tah-t.When the driver is running without drivelines, the compressors are taxed more than usual, which can result in compressor malfunction alarms.Despite the observed alarms and compressor malfunction, the driver passed all functional testing.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.Ce 4119 / 4525.

• 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: 7206068
• MDR Text Key: 98191782
• Report Number: 3003761017-2018-00025
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1