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

Catalog Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited multiple alarms and the patient subsequently switched to another backup freedom driver, however, the patient did not report this event to the customer at that time.The customer also reported that the patient finally shared that "the red light goes on and a solid beep" on the freedom driver.The customer also reported that the patient switched back to the driver that had previously alarmed, but did not feel well when supported by this driver and subsequently switched to another driver.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited previous 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

Added driver serial number.The freedom driver was returned to syncardia for evaluation.Review of the driver alarm history revealed three alarms: one associated with an external power source and two associated with low right drive pressure.The driver did not pass incoming functional testing as the right side driveline peak pressure was below the minimum requirement, thus confirming the alarm history.Investigation testing determined the root cause of the customer-reported fault alarms was a malfunction of the piston and cylinder assembly.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 freedom driver s/n (b)(4) exhibited multiple alarms and the patient subsequently switched to a backup freedom driver, however, the patient did not report this event to the customer at the time of the switch.The customer also reported that the patient finally shared that "the red light goes on and a solid beep" on freedom driver s/n (b)(4).The customer also reported that the patient switched back to freedom driver s/n (b)(4) but did not feel well when supported by this driver and subsequently switched to another driver.

• 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: 5888706
• MDR Text Key: 53569094
• Report Number: 3003761017-2016-00269
• 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: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• 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: 08/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2012
• 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: 51 YR