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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Audible Prompt/Feedback Problem (4020)

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

Event Date 04/06/2020

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.Ce (b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient's caregiver woke up hearing the freedom driver alarming, went into patient's room and reported that the driver was not pumping, but the green lights were illuminated on the freedom driver power adapter and the freedom ac power supply power brick.Caregiver started the backup freedom driver and as soon as he connected the blue cannula, the patient woke up and asked what he was doing.Caregiver finished changing over to the backup freedom driver and within 5 mins that driver began having a continuous fault alarm but was still pumping (mfr report # 3003761017-2020-00115).Caregiver's grandson had called 911 and the fire department responded to the house.The hospital mcs staff spoke to the fire department who reported that the patient was unresponsive with copious amounts of pink frothy sputum; he was difficult to intubate at this time.The driver readings were cardiac output 4 lpm and fill volume 40 ml.Per caregiver, the patient was telling him and grandson that he loved them while being brought to the ambulance.Mcs staff met patient and fire department in er and immediately changed him to a companion 2 driver.Once on the companion 2 driver the readings were cardiac output < 0.5 lpm bilaterally, fill volume <5ml bilaterally.A backup companion 2 driver was powered on, and the settings set to primary driver and patient was placed on it to verify cardiac output, fill volume and waveforms.All were identical, patient as then changed back to primary companion 2 driver on hospital caddy.Both freedom drivers where continuously fault alarming upon patient's arrival.Patient's neuro exam was flat, no response to painful stimulus, very sluggish and minimal pupillary activity.Blood was noted in oro/nasopharyngeal cavities.Patient was hypotensive and resuscitated with fluids and pressor support (levophed and epinephrine gtts) in er.Per fire department patient was difficult to bag and intubate.He presented with a 5.5 et tube in the er.(this was subsequently exchanged for a 7.5 once in the cvicu.) for roughly 30 minutes, companion 2 driver displayed flows of < 2.5 lpm bilaterally.After administering 4 amps of bicarb, his cardiac output and blood pressure then normalized with cardiac output of 4.8 lpm bilaterally.Patient was transported to cvicu at 0345.Cardiac output and fill volumes wax and waned over the next couple hours while trying to stabilize the patient's hemodynamics and ascertain a neuro exam.Lab work revealed a lactic acid of 23, and a rise in liver enzymes as well as a 5 pt drop in hgb (from 12.8 to 7).Neuro consult was placed, and initial exam completed, however, the patient had received paralytic agents 2 hrs prior for his ett exchange.Patient had very sluggish pupillary response with no cough and no gag response.40mg ivp lasix x1 yielded < 100 ml urine output.Around 0600, patient began to have more bloody output from nose and mouth, it was also noted that all iv sites were beginning to ooze, and the attempted insertion site of a central line in the er began to form a hematoma.A dic panel was sent.Vasopressin was added, patient had been on levophed and epinephrine drips all night.Bp continued to dwindle; if no fluids were running the patient would become more hypotensive.After 0700, cardiac output began to drop again on companion 2 driver, sustaining between 1.8-3.0 lpm bilaterally.It was recommended the family come for end of life visitation.Support was withdrawn, autopsy will be performed.

Manufacturer Narrative

Visual inspection of the freedom driver revealed an abrasion on the drivelines, physical damage on the front and rear housings, the secondary motor's cam follower to be out of the bottom dead center (bdc) position, metallic debris on top of the motors and piston cylinder assembly (pca) and a groove carved into the pca's scotch yoke guide wall on the dowell pin of the primary side of the scotch yoke.The driver's alarm history was reviewed and revealed the presence of three new alarm types - a 1e, 4a, and 0f.The 1e alarm is produced by a sudden drop in voltage detected by the mpu, or can be produced as a result of an impact shock or sudden movement that causes an onboard battery that is not fully latched in place to have an intermittent electrical connection.The 4a alarm is typically produced after the driver is disconnected from a load (i.E.The patient), and the 0f alarm is an alarm that indicates no pumping action detected by the pca sensors and it is recorded as the result of the primary motor not engaging.If the primary motor does not engage, the driver will switch to secondary motor engagement, which will cause the scotch yoke to change positions.The 1e was likely the customer-reported alarm and was likely caused by an impact shock, as evidenced by the physical damage to the driver.This sudden movement could have caused the driver to switch to secondary motor operation.Due to mechanical binding of the scotch yoke with the pca, the secondary motor was not able to produce pneumatic pumping action.It is likely that an impact shock contributed to the binding of the scotch yoke.The root cause of the customer-reported alarm and no pumping was due to the driver operating on secondary operation (alarm) likely due to an impact shock, and the secondary motor not being able to provide pneumatic power due to mechanical binding that caused the scotch yoke of the pca to seize when the driver went into secondary operation.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.Ce 5263 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, az ; 5451234120
• MDR Report Key: 10007251
• MDR Text Key: 189248441
• Report Number: 3003761017-2020-00113
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• 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: 04/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• 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; Hospitalization; Required Intervention
• Patient Age: 40 YR