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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Device Emits Odor (1425); Audible Prompt/Feedback Problem (4020)

Patient Problems Hematoma (1884); Seizures (2063); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

The freedom driver s/n (b)(4) will be returned to syncarida for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that freedom driver s/n (b)(4) exhibited a fault alarm.When the hospital staff responded to the alarm, they noticed a burning metallic smell coming from the freedom driver s/n (b)(4).The customer reported the hospital staff attempted to change out the batteries (s/ns to follow), but were having some difficulty.During this time the freedom driver reportedly stopped.The customer also reported they switched the patient to her backup freedom driver s/n (b)(4).She was unconscious for approximately 90 seconds and was intubated.The customer also reported that a burning metallic smell was coming from the backup freedom driver s/n (b)(4) so they switched her to a c2 driver (sn to follow).There was no documentation of either driver being dropped or exposed to fluid.A ct scan of the patient's head was done which showed no acute abnormality.Neurology was consulted and noted that the patient was twitching (possible seizure activity) and that they were going to start her on keppra.The customer also reported that the patient was following commands, giving thumbs up and that she had equal strength bilaterally.The customer also provided an update on the patient indicating that she was extubated the evening of the reported freedom driver stoppage ((b)(6) 2020) and was reportedly intact neurologically.Following this episode, the patient had a headache that increased in severity and that was not resolved with treatment.On (b)(6) 2020, a ct of the head was done which showed subdural hematomas.Neuro assessments were done by the study neurologist.The crc at the site reported that there were no stroke-related deficits.

Event Description

Additional information: the customer reported that the patient improved, with decreasing dizziness and headache.A head ct performed on (b)(6) 2020 revealed the right-side hematoma had decreased in size and the left side hematoma had resolved.A head ct performed on (b)(6) 2020 showed continuing resolution of the right-side hematoma and no new acute abnormalities.

Manufacturer Narrative

Visual inspection of the driver revealed blistering/delamination on the main printed circuit board assembly (pcba).Burn marks were also observed on the left battery well, left battery well base, and left battery pcba.Both of these observations most likely confirm the reported burning smell.The customer-reported fault alarm was unable to be reproduced as the driver could not be powered on due to the damage to the main pcba.The alarm history was reviewed and revealed a recording of a '46' fault code which was likely the reported alarm and recorded as a result of the main pcba malfunction.Further evaluation of the main pcba determined that damage at the cathode side of the diode at d5 on the circuit board caused over current/temperature.This was most likely a result of a malfunction of the integrated circuit at u7 which failed to turn on q7 while in forward bias mode causing excessive heating of d5 and q7 diodes.The excessive heating eventually caused d5's cathode lead to de-solder and open.Q7 continued to flow current through its internal body diode and continued to overheat materials in the pcb to the point where internal shorts formed between driver power bus and ground.Grounding the driver power bus will prevent the driver from operating, confirming the customer-reported driver stop.After the main pcba was replaced the driver passed all functional testing.During investigation testing, the driver did not operate, thus confirming the customer-reported issue.The root cause was determined to be a malfunction of the main pcba.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5198 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 85713
• MDR Report Key: 9722328
• MDR Text Key: 186717685
• Report Number: 3003761017-2020-00068
• 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,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• 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: 02/28/2020
• Date Manufacturer Received: 02/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR