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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

Patient Problem Loss of consciousness (2418)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The connection 1 receptacle is the connector located on the freedom driver housing that connects the power adaptor to the freedom driver.The customer, a syncardia certified hospital, reported that the freedom power adaptor plug was damaged at the freedom driver connection 1 receptacle while supporting a patient.The customer also reported that the patient attempted to fix the connection 1 receptacle with a screwdriver resulting in sparks coming out of the driver and the driver stopping.The customer also reported that the patient lost consciousness and subsequently, the patient's husband switched the patient to the backup driver and the patient regained consciousness.The customer also reported there was no permanent impact to the patient's health.

Manufacturer Narrative

The customer-reported issue of the broken connection 1 receptacle was likely caused by an impact shock or rough handling which aligns with the additional observed damaged of split housings, raised inserts on the left bottom and left top housing bosses, loose driveline clamp and corresponding insert missing from housing boss.The customer reported that the driver stopped when the patient tried to retrieve the broken part of connection 1 receptacle from within the driver with a screwdriver.Visual inspection of the internal components revealed a burn mark on the main printed circuit board assembly (pcba).The location of the burn mark on the board (between r24 and r25 which connects directly to +v batt and to external power) is not consistent in location with entry of a screwdriver through the connector port, but is consistent if the screwdriver were to short the j7b and j7c on the external power connector which is accessible through the connector port.The shorted location is most likely what caused the board to malfunction and the driver to stop.The root cause of the reported driver stop was due to a malfunction of the main pcba, which was observed to have a burn mark on it, possibly caused by the introduction of a metal foreign object (screwdriver) into the driver.Syncardia freedom driver system guidebook for patients and caregivers, section 4.Warnings states "no modifications of this equipment should be performed by any clinician, caregiver or patient." the issue of damaged receptacle one connectors is currently being investigated under a corrective and preventive action (capa).Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4856 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: 8790091
• MDR Text Key: 151017164
• Report Number: 3003761017-2019-00198
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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: 07/16/2019
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR