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

Catalog Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022); Noise, Audible (3273)

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

Event Date 05/07/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom driver displayed "high temperature" fault alarm while supporting a patient.The customer also reported that the patient was switched to the backup driver without any adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver displayed a "high temperature" fault alarm, it did 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 supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver displayed "high temperature" fault alarm while supporting a patient.The customer also reported that the patient was switched to the backup driver without any adverse patient impact.Freedom driver s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the interior and exterior of the driver revealed no abnormalities.The driver passed all testing requirements, which included normotensive and hypertensive settings, with no anomalies, alarms or any unusual heat.The driver was tested for an additional 48 hours and performed as intended with no issues.The customer experience was not duplicated and the root cause of the customer reported alarm could not be determined.The onboard batteries used by the customer were not returned and therefore could not be included in this investigation.A temperature alarm is a recoverable alarm and can occur if the internal temperature of the freedom driver is too hot, or the temperature of the onboard batteries become too hot or too cold.Additionally, if the freedom driver's cooling and air filter systems are partially obstructed, these events can contribute to an overheating event, which can subsequently trigger a temperature alarm as experienced by the customer.The freedom driver performed as intended, and there was no evidence of a device malfunction.The driver was serviced and passed all final performance testing.The customer-reported temperature alarm posed a low risk to the patient because the driver continued to perform 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: 4898729
• MDR Text Key: 6021041
• Report Number: 3003761017-2015-00209
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

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: 06/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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: 62 YR