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

Catalog Number 397002-001

Device Problems Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Dizziness (2194)

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

The customer reported that the companion 2 driver displayed irregular waveform timing while supporting a patient.The customer also reported that the companion 2 driver displayed decreased fill volumes of 44 and 48.The customer also reported that the patient had "off and on" nausea for a few days and felt dizzy.The customer also reported that the patient was subsequently switched to the backup companion 2 driver, and the fill volumes increased to the 60s.The customer also reported that the patient's nausea and dizziness improved.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver displayed irregular waveform timing while supporting a patient.The customer also reported that the companion 2 driver displayed decreased fill volumes of 44 and 48.The customer also reported that the patient had "off and on" nausea for a few days and felt dizzy.The customer also reported that the patient was subsequently switched to the backup companion 2 driver, and the fill volumes increased to the 60s.The customer also reported that the patient's nausea and dizziness improved.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no anomalies.Visual inspection of the internal components revealed contamination inside the right pilot valve.During failure investigation, the customer-reported diastolic waveform delay was reproduced.The root cause was a malfunction of the right pilot valve.The right pilot valve was replaced and the companion 2 driver passed all final performance testing before being placed into finished goods.The customer-reported failure mode posed a low risk to the patient because it did not prevent the driver from performing its life-sustaining functions.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of the complaint and is closing this file.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5626263
• MDR Text Key: 45288603
• Report Number: 3003761017-2016-00160
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• 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: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR