MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC SYNCARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 397002-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

The customer reported that the patient was being supported by a css console.Upon completing a successful companion 2 driver system checkout, the patient was switched from the css console to a companion 2 driver.The customer reported that after the patient was switched to the companion 2 driver, the patient complained he didn't feel well.The custom also reported the companion 2 driver exhibited a "system malfunction" alarm.The patient was switched back to the css console without adverse impact.This alleged failure mode poses a low risk to the patient because it did not prevent the companion 2 driver from performing its life-sustaining functions.An investigation will be conducted by syncardia, and the results will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC; tucson AZ
• Manufacturer Contact: carole marcot, esq., vp ; 1992 e. silverlake rd; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3745666
• MDR Text Key: 4221486
• Report Number: 3003761017-2014-00027
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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