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

Catalog Number 397002-001

Device Problems Erratic or Intermittent Display (1182); Noise, Audible (3273)

Patient Problem Dizziness (2194)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver had noise going across the display screen while supporting a patient.The customer also reported that the companion 2 driver began to make a strange noise and the patient became nervous with subsequent light headedness.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a strange noise, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a followup mdr.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.The driver in "as received" condition displayed electrical noise in the form of a flickering driver touchscreen.This occurrence aligned with the customer-reported description of noise on the display screen.The root cause of the flickering was a malfunction of the driver touchscreen assembly.Visual inspection of the internal components of the driver revealed signs of grinding on the left compressor counterweight.This grinding is the likely root cause of the customer-reported mechanical noise.These issues 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.(b)(4).

Event Description

The customer reported that the companion 2 driver had noise going across the display screen while supporting a patient.The customer also reported that the companion 2 driver began to make a strange noise and the patient became nervous with subsequent light headedness.

• 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
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5928790
• MDR Text Key: 54550063
• Report Number: 3003761017-2016-00307
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• 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: 39 YR