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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom driver s/n (b)(4) will be 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 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 companion 2 driver.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.

Manufacturer Narrative

During investigation testing, the driver passed all sections of functional testing without any alarms, abnormalities or odors.The customer-reported burning smell was not reproduced and there was no evidence of a device malfunction.The root cause of the customer-reported issue could not be conclusively determined; however, it should be noted that the customer did report that the driver was in the same room as a different freedom driver which did have a definitive metallic burning smell and there most likely was residual odor in the room.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) follow-up report 1.

• Brand Name: SYNCARDIA
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• MDR Report Key: 9722235
• MDR Text Key: 188659533
• Report Number: 3003761017-2020-00069
• 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: 06/17/2020

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?: No
• 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 Age: 60 YR