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

Catalog Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that on (b)(6) 2015, the freedom driver exhibited a series of high intermittent fault alarms when the patient would stand up.The customer also reported the patient was asymptomatic at the time of the event.The customer also reported that the patient was subsequently switched to the backup freedom driver.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, 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

(b)(4).

Event Description

The customer reported that on (b)(6) 2015, the freedom driver exhibited a series of intermittent fault alarms when the patient would stand up.The customer also reported the patient was asymptomatic at the time of the intermittent fault alarms.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Review of the alarm history (eeprom) revealed that no fault alarms were recorded while the driver was supporting the patient.Only permanent fault alarms are recorded in the alarm history.Intermittent, recoverable and battery alarms are not recorded in the eeprom.During functional testing, the driver met all test acceptance criteria, which included normotensive and hypertensive settings, with no anomalies or unintended alarms.The driver was tested for an additional 68.5 hours, and it performed as intended with no intermittent or permanent fault alarms.The reported intermittent fault alarms were not functionally reproduced.The driver performed as intended, and there was no evidence of a device malfunction.The reported issue posed a low risk to the patient because although the freedom driver exhibited intermittent fault alarms, the freedom driver continued to perform its life-sustaining functions.The patient was switched to the backup driver without adverse impact.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: 5141969
• MDR Text Key: 28377499
• Report Number: 3003761017-2015-00351
• Device Sequence Number: 1
• Product Code: LOZ
• 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: Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• 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: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2013
• 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: 22 YR