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

Model Number 397002-001

Device Problems Device Operational Issue (2914); Failure of Device to Self-Test (2937)

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

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

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.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that the companion 2 driver did not pass the system check procedure.

Manufacturer Narrative

The customer determined that the companion 2 driver was not seated properly in the companion driver caddy at the time of the reported issue.After the customer correctly inserted the driver into the caddy, the driver passed several system checks and performed as intended.The customer is satisfied with the performance of the driver is not returning it to syncardia for evaluation.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.(b)(4) follow-up report 1.

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that the companion 2 driver did not pass the system check procedure.

• 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: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6931967
• MDR Text Key: 90296883
• Report Number: 3003761017-2017-00197
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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