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

Catalog Number 595000-001

Device Problems Difficult to Insert (1316); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This freedom driver was not supporting a patient.The customer reported that it was very difficult to insert and extract onboard batteries from the freedom driver battery wells.This alleged failure mode poses a low risk to a patient because the freedom driver was not supporting a patient when the issue was observed.In addition, it would not prevent the freedom driver from performing its life-sustaining functions, and the freedom driver has a redundant power source of external wall power.The freedom 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 freedom driver was not supporting a patient.The customer reported that it was very difficult to insert and extract onboard batteries from the freedom driver battery wells.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no abnormalities.There was no evidence of any visual defects in the battery wells or on the battery safety latches and battery release latches.The driver was functionally tested and passed all test acceptance criteria, which included normotensive and hypertensive settings, with no anomalies or unintended alarms.In addition, an onboard battery insertion/extraction test was performed, and there were no issues observed.The reported issue could not be reproduced.The freedom driver performed as intended, and there was no evidence of a device malfunction.It is possible that the reported issue was related to the onboard batteries used by the customer at the time of the reported issue.The onboard batteries used by the customer were not returned and could not be evaluated as part of this investigation.The reported issue posed a low risk to a patient because the freedom driver was not supporting a patient when the issue was observed.In addition, it would not prevent the freedom driver from performing its life-sustaining functions, and the freedom driver has a redundant power source of external wall power.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 FREEDOM 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: 5683804
• MDR Text Key: 46308066
• Report Number: 3003761017-2016-00224
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2011
• 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