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

Catalog Number 595000-001

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Dyspnea (1816); Loss of consciousness (2418)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the patient was sitting at home and began to feel ill while supported by his primary freedom driver.The customer also reported that the wife visually confirmed that the freedom driver was plugged into wall power and the freedom onboard batteries were fully charged.The customer also reported that the wife then heard an unusual noise from the freedom driver and it reportedly stopped and the patient lost consciousness and stopped breathing.The customer also reported that the wife switched the patient to the backup freedom driver and the tah-t began pumping.The customer also reported that the patient was resuscitated.The customer also reported that the primary freedom driver exhibited visual and audible alarms after it was taken off the patient.The customer also reported that the patient did not suffer any residual effects.The customer also reported that the patient recalled that prior to the above events he walked with the freedom driver on a cart that he was pulling behind him and the driver fell off the cart onto a carpeted floor.There were no reported alarms at the time of the drop.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

Changed from malfunction to serious injury.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's as-received physical condition revealed the presence of housing damage consistent with the customer-reported driver drop.The damage included a fractured display cover, a fractured housing boss, multiple raised housing boss inserts, and a broken scotch yoke on the piston cylinder assembly (pca).The driver could not be tested in the as-received state because of the broken scotch yoke.However, after replacement of the piston cylinder assembly, both the primary and secondary motor circuits were determined to function as intended.The piston cylinder assembly with broken scotch yoke was submitted to the approved contract laboratory for further evaluation.Based upon the data collected by the approved contract laboratory, syncardia engineering determined that the root cause of the broken scotch yoke was most likely the impact shock sustained during the driver drop.The impact shock resulted in the fracturing of the primary side of the scotch yoke and subsequent fracture of the secondary side of the scotch yoke due to the impact on the secondary motor which rendered the piston cylinder assembly inoperable.This determination is supported by the following: the reported customer experience states that the driver was dropped, and a visual inspection of the driver's physical condition confirmed damage to the driver's internal housing bosses.The analysis by the approved contract laboratory identified evidence of a hard contact, consistent with a dropped driver, on the lower strike plate of the secondary side of the scotch yoke.The nature of the grease distribution on the fracture surface of the scotch yoke and the existence of three distinct broken pieces from the scotch yoke provide evidence that the observed damage to the scotch yoke was not the result of a single event.After the drop, the patient had not replaced the dropped driver as directed by the instructions for use and training received from the hospital staff, but continued using the driver.Continued operation of the freedom driver on the damaged scotch yoke eventually led to a complete fracture on the primary side and the primary motor was rendered inoperable.An inoperable primary motor would have caused activation of the secondary motor.It is likely that the scotch yoke fracture on the secondary side occurred when the secondary motor activated and impacted the already damaged scotch yoke.This is the first and only known occurrence of a complete fracture of the scotch yoke on both the primary and secondary sides.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 was sitting at home and began to feel ill while supported by his primary freedom driver.The customer also reported that the wife visually confirmed that the freedom driver was plugged into wall power and the freedom onboard batteries were fully charged.The customer also reported that the wife then heard an unusual noise from the freedom driver and it reportedly stopped and the patient lost consciousness and stopped breathing.The customer also reported that the wife switched the patient to the backup freedom driver and the tah-t began pumping.The customer also reported that the patient was resuscitated.The customer also reported that the primary freedom driver exhibited visual and audible alarms after it was taken off the patient.The customer also reported that the patient did not suffer any residual effects.The customer also reported that the patient recalled that prior to the above events he walked with the freedom driver on a cart that he was pulling behind him and the driver fell off the cart onto a carpeted floor.There were no reported alarms at the time of the drop.

• 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: 5867051
• MDR Text Key: 52839220
• Report Number: 3003761017-2016-00264
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• 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: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2012
• 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 Age: 56 YR