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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue did not prevent the driver from performing its life-sustaining function.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient was at a football game in approximately 19 degree fahrenheit temperatures for 2.5 hours when his freedom driver exhibited a fault alarm.Patient's wife checked the drivelines, changed the batteries, which were also outside in the low temperatures, but the fault alarm continued.The customer also reported that the patient was subsequently switched to the backup freedom driver which had been in the car.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of the driver revealed no abnormalities.The driver passed incoming functional test requirements.Additionally, the driver was subjected to an extended 48 hour observation run where it performed as intended with no abnormalities or alarms.The returned onboard batteries were also tested and all successfully passed final test acceptance criteria with no abnormalities.A temperature alarm can be produced if the temperature of the onboard batteries is too hot or too cold.The freedom driver system operator manual (f-900013) has multiple precautions and warnings about the freedom driver's use in cold temperatures, detailed below.- section 5.1 precautions: "avoid exposing the freedom driver system to extreme temperatures for more than brief periods of time" - section 10.2 temperature alarm: "the issue that caused the alarm must be immediately addressed by performing the following steps", which include moving the freedom driver into a climate controlled environment (a warmer area).- section 10.2 caution: "do not ignore a temperature alarm.An unresolved temperature alarm may become a permanent fault alarm." - section 17.2 maintenance and cleaning instructions: "do not expose the freedom driver to temperatures higher than 40°c (104°f) or lower than 4.5°c (40°f) for long periods." - section 17.2.4 onboard batteries: "store the onboard batteries in a cool, dry place and within a temperature range of 0°c to 40°c (32°f to 104°f).Charge onboard batteries within a temperature range of 0°f to 40°c (32°f to 104°f)." and "do not leave the onboard batteries exposed to extreme heat or cold.Extreme high and low temperatures can damage the onboard batteries." - section 18.6 environmental conditions: "operating temperature (driver): 4.5° to 40°c (40° to 104°f).Operating temperature (accessories): 4.5° to 40°c (40° to 104°f).Transportation/storage temperature: -25° to 70°c (-13° to 158°f)." the reported temperature that the driver and onboard batteries were exposed to was outside of the recommended operating range (below 40°f for the driver and 32°f for the onboard batteries), but within the transportation/storage temperature range which goes down to -13°f.Although the driver and accessories should not be operating in these conditions, this investigation determined that there was no device malfunction caused by the driver and onboard batteries being exposed to these conditions.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4582 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNUEMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8148378
• MDR Text Key: 129903406
• Report Number: 3003761017-2018-00546
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR