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

Catalog Number 595000-001

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problems Vomiting (2144); Loss of consciousness (2418); Confusion/ Disorientation (2553)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

The customer reported that the patient was supported by freedom driver 4708 for 40 days, and on (b)(6) 2015, the freedom driver exhibited a fault alarm.The customer also reported that at the time of the fault alarm, the patient was at home on his bed, working on his laptop, and the freedom driver was inside the freedom backpack, plugged into external wall power with the ac power supply.The customer also reported that there were no symptoms prior to the sound of the fault alarm and the patient called for help before losing consciousness.The customer also reported that family members heard the patient's call for help and the sound of the fault alarm and arrived to the patient's room within 5-10 seconds with the backup freedom driver.The customer also reported that the family members did not hear the freedom driver pumping, they only heard the sound of the fault alarm.The customer also reported that the family members switched the patient to the backup freedom driver in less than 2.5 minutes.The customer also reported that within three seconds of the driver switch, the patient became responsive.The customer also reported that the patient was disoriented for two minutes and vomited, but within ten minutes, the patient was able to walk around the house.The customer also reported that the patient was admitted to the hospital the next day and that the patient did not suffer any residual effects.The freedom driver was 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 patient was supported by freedom driver 4708 for 40 days, and on (b)(6) 2015, the freedom driver exhibited a fault alarm.The customer also reported that at the time of the fault alarm, the patient was at home on his bed, working on his laptop, and the freedom driver was inside the freedom backpack, plugged into external wall power with the ac power supply.The customer also reported that there were no symptoms prior to the sound of the fault alarm and the patient called for help before losing consciousness.The customer also reported that family members heard the patient's call for help and the sound of the fault alarm and arrived to the patient's room within 5-10 seconds with the backup freedom driver.The customer also reported that the family members did not hear the freedom driver pumping; they only heard the sound of the fault alarm.The customer also reported that the family members switched the patient to the backup freedom driver in less than 2.5 minutes.The customer also reported that within three seconds of the driver switch, the patient became responsive.The customer also reported that the patient was disoriented for two minutes and vomited, but within ten minutes, the patient was able to walk around the house.The customer also reported that the patient was admitted to the hospital the next day and that the patient did not suffer any residual effects.Freedom driver s/n 4708 was returned to syncardia for evaluation.An extensive investigation of the affected freedom driver revealed the root cause was a failure in the freedom motor gearbox that occurred as a result of unauthorized rework by a component sub-supplier.As a result of this investigation, syncardia informed the fda on 06 august 2015 that it would conduct a voluntary recall of 29 affected freedom drivers in the us (recall # z-2731-2015).All us patients on affected freedom drivers were switched to unaffected freedom drivers by 12 august 2015.There was no other adverse events for the failure in the motor/gearbox assembly.The fda terminated the recall on 04 november 2015.Freedom driver s/n (b)(4) was taken out of service.Syncardia has completed its evaluation of this complaint and is closing this file.

Manufacturer Narrative

The customer also reported that the family members switched the patient to the backup freedom driver in less than 2.5 minutes.The customer also reported that within three seconds of the driver switch, the patient became responsive.The customer also reported that the patient was disoriented for two minutes and vomited, but within ten minutes, the patient was able walk around the house.The customer also reported that the patient was admitted to the hospital the next day and that the patient did not suffer any residual effects.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's exterior components revealed no abnormalities.Visual inspection of the driver's internal components revealed fractured screw bosses at the top left and bottom right of the housing.The fractured screw bosses are known to occur as a result of the driver experiencing an impact shock.Inspection of the pca and motor/gearbox assemblies revealed: broken scotch yoke within the piston cylinder assembly (pca).Secondary motor cam follower at top dead center.The broken cam follower and damaged scotch yoke are the root cause for the fault alarm and cessation of the driver pumping as experienced by the patient.The root cause for the detachment of the cam follower from the motor/gearbox assembly could not be determined.The motor/gearbox assembly was sent to a third party laboratory for further analysis.The results of the investigation will be provided in a supplemental mdr.This issue will continue to be monitored and trended as part of the customer experience process.

Event Description

The customer reported that the patient was supported by freedom driver 4708 for 40 days, and on (b)(6) 2015, the freedom driver exhibited a fault alarm.The customer also reported that at the time of the fault alarm, the patient was at home on his bed, working on his laptop, and the freedom driver was inside the freedom backpack, plugged into external wall power with ac power supply.The customer also reported that there were no symptoms prior to the sound of the fault alarm and the patient called for help before losing consciousness.The customer also reported that family members heard the patient's call for help and the sound of the fault alarm and arrived to the patient's room within 5-10 seconds with the backup freedom driver.The customer also reported that the family members did not hear the freedom driver pumping, they only heard the sound of the fault alarm.

Manufacturer Narrative

(b)(4).Please note that this is a corrected report.The freedom driver was not taken out of service.Freedom driver s/n (b)(4) was serviced, which included the replacement of the housings, piston cylinder assembly (pca), and motor/gearbox assemblies, before being placed in finished goods.

Event Description

The customer reported that the patient was supported by freedom driver 4708 for 40 days, and on (b)(6) 2015, the freedom driver exhibited a fault alarm.The customer also reported that at the time of the fault alarm, the patient was at home on his bed, working on his laptop, and the freedom driver was inside the freedom backpack, plugged into external wall power with the ac power supply.The customer also reported that there were no symptoms prior to the sound of the fault alarm and the patient called for help before losing consciousness.The customer also reported that family members heard the patient's call for help and the sound of the fault alarm and arrived to the patient's room within 5-10 seconds with the backup freedom driver.The customer also reported that the family members did not hear the freedom driver pumping; they only heard the sound of the fault alarm.The customer also reported that the family members switched the patient to the backup freedom driver in less than 2.5 minutes.The customer also reported that within three seconds of the driver switch, the patient became responsive.The customer also reported that the patient was disoriented for two minutes and vomited, but within ten minutes, the patient was able to walk around the house.The customer also reported that the patient was admitted to the hospital the next day and that the patient did not suffer any residual effects.Freedom driver s/n (b)(4) was returned to syncardia for evaluation.An extensive investigation of the affected freedom driver revealed the root cause was a failure in the freedom motor gearbox that occurred as a result of unauthorized rework by a component sub-supplier.As a result of this investigation, syncardia informed the fda on 06 august 2015 that it would conduct a voluntary recall of 29 affected freedom drivers in the us (recall # (b)(4)).All us patients on affected freedom drivers were switched to unaffected freedom drivers by 12 august 2015.There was no other adverse events for the failure in the motor/gearbox assembly.The fda terminated the recall on 04 november 2015.Freedom driver s/n (b)(4) was serviced, which included the replacement of the housings, piston cylinder assembly (pca), and motor/gearbox assemblies, before being placed in finished goods.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 (Section G): 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: 4808810
• MDR Text Key: 20441513
• Report Number: 3003761017-2015-00155
• Device Sequence Number: 1
• Product Code: LOZ
• 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 Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• 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: 05/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2014
• 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: 29 YR