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

Catalog Number 595000-001

Device Problem Difficult to Insert (1316)

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

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This freedom driver was not supporting a patient.The customer reported that although the freedom driver passed the system check when it arrived at the hospital, it was difficult to insert an onboard battery into one of the battery wells.This alleged failure mode poses a low risk to the patient because the issue was observed when the freedom driver was not supporting a patient.In addition, it would not prevent the freedom driver from performing its life-sustaining functions.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 although the freedom driver passed the system check when it arrived at the hospital, it was difficult to insert an onboard battery into one of the battery wells.The freedom driver was returned to syncardia for evaluation.The onboard batteries used by the customer at the time of the reported issue were not returned to syncardia and were not included in this investigation.Visual inspection of the driver's external and internal components revealed no abnormalities.The battery wells and battery latches were visually inspected and confirmed to not be damaged.The driver was functionally tested and passed all test acceptance criteria, which included pressure test requirements associated with normotensive and hypertensive settings, with no unintended alarms.When an onboard battery was inserted into the right battery well, there was resistance, although the onboard battery was able to be fully inserted into the right battery well.The driver front and rear housings were inspected for further inspection of the battery latches and safety latches.Additional testing revealed that the right battery latch bar intermittently bound with the left battery latch bar, which prevented the right battery latch in the right battery well from being released and remained stiff.This binding prevented an onboard battery from being inserted into the right battery well.The root cause of the reported issue was a malfunction of the battery latch bars that prevented the right battery latch from being released and remained stiff, which made it difficult to insert an onboard battery.The battery latches and battery safety latches were replaced during service, and the freedom driver passed all final performance testing.This failure mode posed a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.In addition, it would not prevent a freedom driver from performing its life-sustaining functions.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: 5626194
• MDR Text Key: 44805468
• Report Number: 3003761017-2016-00178
• 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: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• 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: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2014
• 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