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

Catalog Number 595000-001

Device Problems Filling Problem (1233); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

The customer reported that the freedom driver exhibited intermittent fault alarms for low fill volumes while supporting a patient.The customer also reported that the freedom driver exhibited fluctuating fill volumes between 41 - 50.The customer also reported that the patient was switched to the backup freedom driver, and the patient's fill volumes were 50 - 57.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited intermittent fault alarms and fluctuating fill volumes, the freedom driver continued to perform 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

The freedom driver was returned to syncardia for evaluation.The driver passed all functional test requirements with no anomalies or alarms.Further, an extended observation run was performed and the testing did not reproduce the customer-reported issue.While the cause for the reported intermittent alarms could not be determined, there is no evidence of a device malfunction based upon inspection and functional testing.It is possible that patient conditions, which were not reproducible through investigation, were a contributing factor to the low fill volume readings and subsequent intermittent fault alarms.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).

Event Description

The customer reported that the freedom driver exhibited intermittent fault alarms for low fill volumes while supporting a patient.The customer also reported that the freedom driver exhibited fluctuating fill volumes between 41 - 50.The customer also reported that the patient was switched to the backup freedom driver, and the patient's fill volumes were 50 - 57.There was no reported adverse patient impact.

• Brand Name: SYNCARDIA FREEDOM 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: 5651018
• MDR Text Key: 46266134
• Report Number: 3003761017-2016-00198
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/05/2016

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: Lay User/Patient
• 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: 05/05/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2012
• 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: 56 YR