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

Catalog Number 595000-001

Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

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

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that it was difficult to insert a battery into the patient's backup freedom driver.This alleged failure mode poses a low risk to the patient because the issue was observed when the backup freedom driver was not supporting a patient.In addition, it would not prevent the driver from performing its life sustaining function.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

The customer reported that it was difficult to insert an onboard battery into the patient's backup freedom driver.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no abnormalities.Visual inspection of the driver's internal components revealed no evidence of subsequent damage to any of the battery wells.Functional testing confirmed no issues with inserting or extracting test onboard batteries.In addition, an onboard battery insertion/extraction test was performed with two fully charged onboard batteries.No insertion or extraction issues were observed.The customer-reported onboard battery insertion issue was not reproduced and, therefore, could not be confirmed.During failure investigation testing, the driver performed as intended, and there was no evidence of a device malfunction.The driver was serviced and passed all final performance testing.The customer-reported issue poses a low risk to the patient because the issue was observed when the backup freedom driver was not supporting a patient.In addition, it would not prevent the driver from performing its life sustaining function.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: 5704157
• MDR Text Key: 48014290
• Report Number: 3003761017-2016-00234
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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 faci
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• 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: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• 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
• Patient Age: 49 YR