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

Catalog Number 595000-001

Device Problems Computer Software Problem (1112); Nonstandard Device (1420); 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 02/19/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a pt.The customer also reported that the reason for the fault alarm was "unclear".The pt was subsequently went to the hospital and switched to a backup freedom driver.There was no reported adverse pt impact.This alleged failure mode poses a low risk to the pt because although the freedom driver from driver exhibited a fault alarm, the driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.

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 reason for the fault alarm was "unclear." the patient subsequently went to the hospital and switched to a backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components did not reveal any anomalies or abnormalities.Visual inspection of the driver's internal components revealed fractured housing bosses and raised inserts on the top and bottom left of the housing and a broken exhaust fan wire, which caused the exhaust fan to not operate.This damage is consistent with an impact shock to the driver.Review of the alarm history electronic data confirmed that the driver did not record a permanent fault alarm while supporting the patient.Only permanent fault alarms are latched in the electronic record.Intermittent, recoverable, and battery alarms are not recorded.The electronic record indicated a "left drive pressure too low for long enough to be permanent time-out" fault alarm, which was result of the patient being switched to the backup driver.The driver in "as received" condition passed all required functional testing requirements, with the exception of the exhaust fan being operational, which included normotensive and hypertensive settings, with no alarms.In addition, the driver was tested for an additional 66 hours and was observed to alarm as a result of the exhaust fan malfunction.The root cause of the customer-reported fault alarm was a malfunction of the exhaust fan caused by the broken wire.The internal temperature of the onboard batteries exceeded the maximum recommended operating temperature of 40 deg c as stated on the s/n label of the driver and onboard batteries, which likely resulted in a "left battery too hot" fault alarm.Prior to a fault alarm becoming permanent, the fault alarm (e.G., "high temperature" or "left battery too hot") must persist for thirty minutes to become recorded in the driver's alarm history.Therefore, the patient switched to the backup driver prior to the alarm being recorded in the driver's alarm history.The onboard batteries utilized by the customer were not returned; therefore, they could not be evaluated and were not included in this report.Despite the customer-reported fault alarm, risk to the patient was low because the driver continued to perform its life-sustaining functions.The freedom driver was serviced that included the replacement of the housing and exhaust fan.The driver passed all functional and performance testing before being placed into finished goods.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: 4589774
• MDR Text Key: 19353817
• Report Number: 3003761017-2015-00080
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• 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: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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: 68 YR