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

Model Number 595000-001

Device Problem Output Problem (3005)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 09/21/2021

Event Type  Injury  

Event Description

The customer, a syncardia certified hospital, reported that on (b)(6) 2021 at 9 pm the patient's freedom driver alarmed and there was no to minimal flow detected.The fill volumes (fv) were noted to be 15-20 ml and cardiac output (co) 2 lpm.The patient was emergently transferred to the companion 2 driver and noted to have normal co and normal fv (co 5.3-5.6 lpm, fv 43-56 ml).Patient was given 250 ml of albumin throughout the process to help with the initial low fill volume and was given a breathing treatment as she reported severe shortness of breath.Nurses sent an arterial blood gases (abg) that showed appropriate oxygenation and co2, but a lactate of >6.Her lactate elevation is likely a result of her no flow state.Once the patient was stabilized on the companion 2 driver at settings of beat rate 120 bpm, systolic ejection of 55%, left pressure 180, right pressure 70, and bilateral vacuum of -10 her fills also stabilized.A chest e-ray (cxr) was also performed that showed no pneumothorax, pleural effusion or obvious disruption of the tah/driveline.The patient reported she "felt better" once transitioned to the companion 2 driver and her saturations also improved to 98%.Nurses continued to monitor throughout the night and made adjustments as needed.Patient has abnormal lab work with white blood cell count (wbc) up 25 k from 16 k.

Manufacturer Narrative

External and internal visual inspection revealed damage to the product label, a cracked front house boss and the secondary motor out of bottom dead center (bdc) position.The driver's alarm history was reviewed and revealed two alarm fault codes, 2d and 49, which are most likely the alarms reported by the customer.The freedom driver passed all incoming functional test requirements.Additionally, the driver underwent a 48-hour extended observation run with no issues or alarms observed.The conditions that caused the secondary motor cam follower to move out of bdc position cannot be conclusively determined, but it is possible that it occurred due to a drop, near drop, jolt, or other rough handling of the driver.Once the secondary motor engages, the freedom driver is designed to record a 2d fault code and annunciate a permanent fault alarm.Despite the observed secondary motor moved out of bdc position, functional testing confirmed that the driver functioned as intended on both the primary and secondary motor circuits.In an attempt to reproduce the low cardiac output alarm recorded during the customer-reported event, driveline kink testing was performed to induce a low cardiac output (co) and low fill volume (fv) state because there was no malfunction or abnormality found associated with the piston cylinder assembly (pca), flow sensor or sensor cable.To perform this test, the driver was first allowed to run for 15 minutes.Then, the drivelines were kinked; after a few seconds, the driver alarmed for low co and the driver displayed asterisks for fv and co.The drivelines were then unkinked and the low co alarm resolved.Next, testing was repeated and the driver was allowed to run in the alarm state for over four minutes and 15 seconds.The drivelines were then unkinked but the alarm did not resolve, as expected.A new alarm reading was extracted from the driver and an additional 49 fault code alarm was recorded as a result of low cardiac output for longer than 4 minutes 15 seconds.The conditions that caused the 49 fault code could not be conclusively determined as the driver performed as intended during testing.It is possible for the alarm to occur due to kinking of the drivelines for over four minutes and 15 seconds as observed during additional testing.During driveline inspection no marks or abrasions were observed.The drivelines still could have been kinked; the material is supple and returns to its original state even after kinking.The root cause of the customer-reported freedom driver fault alarms and low fill volume and cardiac output could not be conclusively determined.The driver performed as intended with no evidence of a device malfunction.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 12669604
• MDR Text Key: 281402377
• Report Number: 3003761017-2021-00195
• 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
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2018
• 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): Life Threatening; Required Intervention
• Patient Age: 52 YR