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

Catalog Number 595000-001

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This freedom driver was not supporting a patient.The customer reported that onboard batteries are too easily inserted in and extracted from the left battery well of the freedom driver.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, the reported issue would not prevent the freedom driver from performing its life-sustaining functions.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 onboard batteries were too easily inserted in and extracted from the left battery well of the freedom driver.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external and internal components revealed no anomalies.The driver was functionally tested and passed all test requirements associated with nominal normotensive and hypertensive settings with no anomalies.Functional testing also confirmed proper operation of the battery latches and safety latches in both battery wells.An additional onboard battery insertion/extraction test was conducted, using ten different onboard batteries.No insertion or extraction issues were observed, and the reported onboard battery fit issue was not reproduced.The freedom driver performed as intended, and there was no evidence of a device malfunction.The onboard batteries used by the customer at the time of the reported issue were not returned and could not be evaluated in this investigation.It is possible that there was an issue with the customer's onboard batteries.The driver was serviced and passed all final performance testing.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, the reported issue would not prevent the freedom driver from performing its life-sustaining functions.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: 5651098
• MDR Text Key: 46284630
• Report Number: 3003761017-2016-00200
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2011
• 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