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); Output Problem (3005)

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

Event Date 11/11/2017

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 has been 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 certified hospital, 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 single compressor malfunction alarm was confirmed via a review of the patient data file.The single compressor malfunction alarm was found to have occurred within two minutes of startup.Comparing this against the parameters observed one minute prior to the alarm show that the drivelines were not connected to a patient or mock tank load, which can result in a single compressor malfunction alarm.The customer-reported system malfunction alarms were also confirmed by review of the patient data file and alarm history.The two resulting fault codes observed in the driver were '3d' and '35' fault codes.The functional inspection determined the '3d' alarm to be the result of faulty solder joints on the left and right vacuum connector connections on the main pcb (printed circuit board) assembly (lack of solder coverage on board headers j11 and j19).While the root cause of the insufficient solder coverage cannot be determined, it is likely the result of a production defect at the time the header was populated to the pcb.The functional inspection identified that a '35' fault code could by triggered by incomplete setting of the key switch.Manipulation of the key switched proved that a system malfunction alarm can be recorded if the key switch is improperly or incompletely turned.The root cause of this cannot be confirmed, but is likely the result of improper use.The key should not be left in the driver during patient support.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: 7052561
• MDR Text Key: 93604537
• Report Number: 3003761017-2017-00233
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• 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: 11/13/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR