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

Catalog Number 397002-001

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 05/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver made a "fan sound"over a 24 hour period while supporting a patient.The customer also reported that the noise became progressively louder.The customer also reported that she changed both filters, but the noise did not change.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a fan sound, 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 follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver made a "fan sound" over a 24 hour period while supporting a patient.The customer also reported that the noise became progressively louder.The customer also reported that she changed both filters, but the noise did not change.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.During investigation testing, the reported noise was confirmed.Further testing isolated this noise to the left and right vacuum blowers.The noise from the left and right vacuum blowers did not affect the driver's performance.The left and right vacuum blowers were replaced, the reported noise was resolved, and the companion 2 driver passed all final performance testing.The reported issue posed a low risk to the patient because the companion 2 driver continued to perform 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 this 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: 5642641
• MDR Text Key: 45888028
• Report Number: 3003761017-2016-00195
• 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: 05/01/2016

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: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2012
• 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 Age: 42 YR