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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom driver became hot when disconnecting from wall power.The customer also reported this occurred for several weeks and was often accompanied by a temperature alarm.The customer also reported that the patient was switched to the backup driver wi/out any patient impact.The freedom driver will be returned to syncardia for evaluation.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 became hot when disconnecting from wall power.The customer also reported this occurred for several weeks and was often accompanied by a temperature alarm.The customer also reported that the patient was switched to the backup driver without any patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed no abnormalities.The driver in "as received" condition passed all required functional testing requirements, which included nominal normotensive and hypertensive settings with no anomalies or alarms.The driver was tested for an additional 46.9 hours at normotensive settings and no abnormalities or indications of unusual heating were observed.The customer-reported temperature alarm was not duplicated.The electronic data did not record the occurrence of a permanent fault alarm.Only permanent fault alarms are recorded in the electronic record; intermittent, recoverable, and battery alarms are not recorded.Temperature alarms are recoverable and remain steady until they are addressed.The temperature alarms become permanent only if they are not addressed within 30 minutes.The customer experience was not duplicated and root cause of the customer-reported intermittent temperature alarms could not be determined.During investigation testing, there was no evidence of a device malfunction and the driver performed as intended.Per syncardia's freedom driver system guidebook for patients and caregivers - ous, temperature alarms must be addressed immediately by performing any of the following: by replacing each onboard battery, one at a time, with a charged onboard battery; by removing any objects blocking the filter cover and fan on the driver, or; by moving the driver into a climate controlled environment (a cooler or warmer area).The customer-reported intermittent temperature alarms posed a low risk to the patient because they did not prevent the driver from performing its life sustaining-functions.The driver was serviced, which included the replacement of the piston and cylinder assembly (pca), both motors/gearbox assemblies, both motor controller printed circuit board assembly (pcbas), main pcba, speaker pcba, and housings, before being placed into finished goods.The driver met all test performance requirements.There were no anomalies, alarms, or indications of overheating, and the exhaust fan functioned as intended.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: 4922519
• MDR Text Key: 6027257
• Report Number: 3003761017-2015-00218
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 06/21/2015

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: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2015
• Initial Date FDA Received: 07/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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: 55 YR