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

Catalog Number 397002-001

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

This companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver made strange noise while it was pumping.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.In addition, it would not prevent the companion 2 driver from performing 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

This companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver made strange noise while it was pumping.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no anomalies.During investigation testing, a loud high-pitched noise was heard, which confirmed the reported issue.The noise was isolated to the left vacuum blower.The left vacuum blower was replaced, and the noise was no longer heard.The companion 2 driver then passed all performance testing.This failure mode posed a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.In addition, it would not prevent the companion 2 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 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: 5626200
• MDR Text Key: 45237224
• Report Number: 3003761017-2016-00180
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

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: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2011
• 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