MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Model Number 397002-001

Device Problems No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(6).

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver had previously passed the system check but exhibited a compressor malfunction alarm approximately one minute after being attached to patient.There was no reported adverse patient impact.The customer also reported the patient was subsequently switched to a backup driver.

Manufacturer Narrative

The customer-reported issue was confirmed by patient file review.The root cause of the fault alarm was determined to be the driver starting up without a load.Since the companion 2 driver's drivelines are not connected to a patient at driver start up, there is no load on the system.This can cause additional stress on the compressor occasionally causing a single compressor malfunction alarm.The alarm is recorded immediately; however, it does not appear on the companion 2 driver display or annunciate until the gui software has completed its full boot-up which takes approximately two minutes.Investigation testing determined there was no evidence of a device malfunction.Syncardia has a corrective and preventive action (capa) to address this issue.Syncardia has completed its investigation and is closing this file.Ce 5654 follow-up report 1.

• Brand Name: SYNCARDIA COMPANION 2 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: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12451266
• MDR Text Key: 273806161
• Report Number: 3003761017-2021-00181
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 09/04/2021
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• 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
• Patient Age: 55 YR
• Patient Sex: Male