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

Catalog Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.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 a fault alarm, 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).Please note, the initial mdr reported the device serial number as (b)(4), this was corrected to serial number (b)(4).

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.Visual inspection of the external and internal components of the driver revealed no abnormalities.The driver exhibited a fault alarm immediately upon startup.Despite the fault alarm, the driver passed all pressure test requirements and performance metrics associated with nominal normotensive and hypertensive settings.The root cause for the customer reported fault alarm was corrosion of the internal bond wires within the pressure sensor (u22) on the main printed circuit boar assembly (pcba).This corrosion of the u22 bond wires is consistent with observations made in a corrective and preventive action (capa) to address the u22 pressure sensor failures.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with u22 pressure sensor failure events.This failure mode poses a low risk to the patient because the customer reported fault alarm would not prevent the driver from performing its life-sustaining functions.The driver was serviced and passed all functional and performance testing before being placed into finished goods.This issue will continue to 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 (Section G): 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: 5115488
• MDR Text Key: 27254169
• Report Number: 3003761017-2015-00318
• 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: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• 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: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2013
• 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: 27 YR