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

Catalog Number 595000-001

Device Problems No Display/Image (1183); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Loss of consciousness (2418)

Event Date 10/02/2016

Event Type  Death  

Manufacturer Narrative

The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer reported that the patient's wife heard his freedom driver alarm and found the patient unresponsive.The customer also reported that the wife called the cedars-sinai medical center and was connected to a vad coordinator, who was able to hear an audible fault alarm from the freedom driver in the background.The customer also reported that the vad coordinator instructed the wife to check the freedom driver to see if it was pumping.The wife stated that the freedom driver was not pumping and that the display screen was blank.The vad coordinator also stated that she was able to hear over the phone that the driver was not pumping.The customer also reported that the vad coordinator talked the wife through switching the patient to his back-up freedom driver.After the switch, the new freedom driver exhibited no alarms.The customer also reported that the patient remained unresponsive and 911 was called.The patient was transported to the nearest er, which was a (b)(6) hospital and was subsequently transferred to (b)(6) medical center.The customer also reported that the patient expired.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's interior revealed evidence of liquid ingress into the case, dark residue around the primary motor gearbox external surfaces, and a secondary motor controller cable that was not connected.The liquid ingress was evidenced by puddle-like verdigris on the case interior originating at the driveline entry port.The primary motor gearbox was found to display dark residue and resistance to spinning was much greater when compared to the secondary motor.There was evidence of corrosion.During disassembly, the primary motor gearbox was found to be heavily degraded, and any remaining lubricant in the bearings was found to be severely overheated.Analysis of the verdigris suggests that the liquid that came into the driver may have been a chlorinated cleaning (surfactant) solution.The electronic data (eeprom) showed agreement with the customer-reported issue and indicated that the driver ceased pumping.As received, the secondary motor controller cable was intact but not connected to the main printed circuit board assembly (pcba).It could not be conclusively determined why the secondary motor controller cable was not connected to the main pcba in the driver, but the most likely root cause is an incomplete connection during servicing.Investigation testing conducted on the driver resulted in the observation that the primary motor would overheat and eventually alarm, culminating in a switch over to secondary motor operation.Although it could not be definitively proven that the observed evidence of liquid ingress caused the primary motor to stop, a motor gearbox exposed to chlorinated surfactants is likely to experience accelerated wear similar to what was observed within the event primary motor gearbox.Freedom driver s/n (b)(4) stopped because of the cessation of the primary motor gearbox caused by excessive heat generation, coupled with a secondary motor controller cable that was not connected to the main pcba of the driver.Freedom driver system guidebook for patients and caregivers, contains language (section 9.1.1) regarding driver cleaning and maintenance, which instructs the user how the driver is to be handled around liquids and cleaning materials: do not submerge the freedom driver or expose it to water; do not use paint remover, fingernail polish remover, or other solvents anywhere near the freedom driver; use extreme care when cleaning the equipment.Dust the equipment periodically with a soft, clean cloth; if you need to remove heavy dirt from the outside of the freedom driver, use a soft, clean lightly dampened cloth; dampen the cloth with mild soap and water solution and wipe gently; do not soak any item of the freedom driver during cleaning; do not allow water to come in direct contact with the freedom driver electrical connections.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.(b)(4).

Event Description

The customer reported that the patient's wife heard his freedom driver alarm and found the patient unresponsive.The customer also reported that the wife called the cedars-sinai medical center and was connected to a vad coordinator, who was able to hear an audible fault alarm from the freedom driver in the background.The customer also reported that the vad coordinator instructed the wife to check the freedom driver to see if it was pumping.The wife stated that the freedom driver was not pumping and that the display screen was blank.The vad coordinator also stated that she was able to hear over the phone that the driver was not pumping.The customer also reported that the vad coordinator talked the wife through switching the patient to his back-up freedom driver.After the switch, the new freedom driver exhibited no alarms.The customer also reported that the patient remained unresponsive and 911 was called.The patient was transported to the nearest er, which was a non-certified syncardia tah-t hospital and was subsequently transferred to (b)(6) medical center.The customer also reported that the patient expired.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6068439
• MDR Text Key: 58814083
• Report Number: 3003761017-2016-00344
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: Initial,Followup
• Report Date: 10/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2012
• 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 Outcome(s): Death
• Patient Age: 57 YR