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

Model Number 595000-001

Device Problems Appropriate Term/Code Not Available (3191); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2021

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a battery alarm while the driver was plugged into wall power.The patient started to exchange the batteries and the driver exhibited a fault alarm.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to the backup driver.

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Manufacturer Narrative

Alarm history and patient data file review found six new alarms recorded in the driver's eeprom.Three fault code "12" alarms were confirmed to be produced at syncardia during the manufacturing/service process functional testing prior to shipment to customer.The 4b, 36, and 39 fault codes were experienced in the field: a "4b" alarm, "right drive pressure too low for long enough to be permanent time-out", could be generated as a result of damage to the u21 pressure sensor of the main pcba.A "36" alarm, "speaker 2 voltage too low when off", could be generated during onboard battery exchange while operating freedom driver only on battery power or if an onboard battery is not fully latched in place, intermittent communication errors can result in a fault alarm.A "39" alarm, "speaker 2 voltage too high when on" could also be generated during onboard battery exchange while operating freedom driver only on battery power or if an onboard battery is not fully latched in place, intermittent communication errors can result in a fault alarm.Visual inspection of external components revealed a cracked freedom front housing bosses and missing insert, impact damage between mainboard and primary motor and damage to the u21 flow sensor nozzle was observed.A crack was also observed in the scotch yoke of the piston cylinder assembly (pca) and the primary motor controller had possible "burn" mark.Visual inspection of internal components revealed no abnormalities.Freedom driver failed incoming functional testing producing an audible fault alarm before the testing was completed.Driver was placed on dmc tank for an extended observation run test.Driver operated as intended and no alarms were recorded.A battery exchange test was then performed.No alarms were produced during this test.Failure investigation for this complaint confirmed the customer reported fault alarm via alarm history data review.The complaint could not be replicated via observational testing.The root cause of the fault alarm was unable to be determined.No issues were noted with any battery, power supply, or the driver that would cause the alarm experienced by the patient.However there were new fault codes recorded in the drivers eeprom data that are consistent with performing a battery exchange.It was likely the battery exchange performed by the patient caused these faults and the red alarm experienced by the patient, however this by itself is not a device malfunction.(b)(4).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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12771398
• MDR Text Key: 281417339
• Report Number: 3003761017-2021-00215
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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: 40 YR
• Patient Sex: Male