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

Model Number 595000-001

Device Problems Break (1069); Failure to Pump (1502); Use of Device Problem (1670); Noise, Audible (3273)

Patient Problem Loss of consciousness (2418)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer, a syncardia authorized distributor, reported that the patient was at home and accidentally stepped on the side of his freedom driver which then damaged the inlet power connector on the freedom driver.The freedom driver was on the ground at the time and was not plugged into wall power.The customer also reported that the freedom driver continued to work but after a short moment the patient's wife heard a change in the sound of the freedom driver and after a further moment the freedom driver stopped pumping and the patient lost consciousness.The patient's wife immediately exchanged to the backup freedom driver and the patient regained consciousness.The customer also reported that the patient is doing fine and he remained at home.

Manufacturer Narrative

Investigation testing denied the root cause of the freedom driver stop was a malfunction of the main printed circuit board assembly (pcba), which was caused by rough handling likely the result of the patient stepping on the freedom driver as described by the customer.This rough handling applied a force that damaged the main pcba and other driver components.The damaged main pcba delaminated near the battery power trace, leading to total loss of power to the freedom driver.The freedom driver system operator manual (f-900012, section 1.3.6) states that the backup freedom driver is provided to the patient in case the primary freedom driver is dropped, exposed to liquid/debris, subjected to rough handling or has a fault alarm that cannot be resolved.The operator manual further defines rough handling as "knocks, jolts, jumps and falls that may be received by the freedom driver during operation use.Examples of rough handling are: hitting the freedom driver against a hard surface (impact) dropping and catching the driver before it impacts a hard surface (jerking motion)".The operator manual also includes a caution statement that if the freedom driver is dropped or subjected to rough handling, it may sustain damage that will not allow it to provide life-sustaining functions as designed, and if the fault alarm cannot be resolved within three to four minutes, the patient must switch to the backup freedom driver.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4255 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: 7459058
• MDR Text Key: 106585552
• Report Number: 3003761017-2018-00122
• 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: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• 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: 04/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR