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

Model Number 595000-001

Device Problem No Audible Alarm (1019)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be evaluated by syncardia.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

While performing functional testing, a syncardia technician reported that the freedom driver did not annunciate an audible alarm when testing the speaker printed circuit board assembly (pcba).

Manufacturer Narrative

Visual inspection of the freedom driver revealed physical damage on front and rear housings, secondary motor's cam follower out of the bottom dead center (bdc) position, metallic debris on top of motors and piston cylinder assembly (pca), and groove carved into pca's scotch yoke guide wall by the dowel pin on the primary side of the yoke.Because damage to the driver system was observed, damage to the speaker printed circuit board assembly (pcba) was suspected.Inspection found metallic dark debris present inside the right speaker.Investigation testing determined the left speaker performed as intended; the right speaker did not produce an audible alarm.The root cause of the driver not annunciating an audible alarm during functional testing was determined to be an electronic malfunction of the speaker pcba most likely caused by physical damage to the driver.It is possible that the accumulation of metallic debris inside the speaker could have led or contributed to the damage in the speaker electronics.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.Ce 5303 comp-2022-0022 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
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10197687
• MDR Text Key: 197184528
• Report Number: 3003761017-2020-00144
• 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: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• 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