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

Model Number 595000-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Discomfort (2330)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the driver revealed a broken power adaptor connector retaining clip, a crack in the display cover, the secondary motor's cam follower out of the bottom dead center (bdc) position, a disconnected yellow wire from the printed circuit board assembly (pcba) on the primary motor, and evidence of impact shock between the main pcba and primary motor.When the main pcba was removed during testing an insert pulled out of the right battery well.The customer-reported alarm and change in beat rate frequency was due to the driver switching to secondary motor operation (as designed), caused by a malfunction of the primary motor gear-box assembly which had a disconnected wire from the main printed circuit board assembly (pcba).The root cause of the wire disconnection cannot be conclusively determined but could have been caused by an impact shock or rough handling of the driver, which was evidenced by observed physical damage.The customer-reported issue that the patient felt unwell was likely due to the sudden change of beat rate; when the driver switches to secondary motor operation the beat rate defaults to what the secondary motor controller is set at (125 bpm ± 5).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.(b)(4).

Event Description

The customer, a syncardia authorized distributor, reported that the freedom driver exhibited a fault alarm and a beat rate drop from 137 bpm to 127 bpm while supporting a patient.The patient reported feeling dizzy and unwell and had to lie down.The patient was subsequently switched to a backup freedom driver.The customer also reported that the patient was admitted to the hospital for observation and did not experience any clinical problem during his hospital stay and has been doing perfectly fine after the driver exchange.

• 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: don webber ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10786763
• MDR Text Key: 214636675
• Report Number: 3003761017-2020-00213
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• 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: 43 YR