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

Model Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because although the freedom driver showed an output of 10 liters and alarmed, it continued to perform its life sustaining functions.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 customer, a syncardia certified hospital, reported that the freedom driver displayed an output of more than 10 liters and alarmed immediately after being connected to the patient.The customer also reported that the patient was switched to a backup freedom driver.There was no reported adverse patient impact.The customer also reported that the output display and alarm was reproduced on a patient simulator.

Manufacturer Narrative

The customer-reported high cardiac output (>10l/min) and fault alarm could not be reproduced during investigation testing, and the root cause could not be conclusively determined.Visual inspection of the driver revealed no abnormalities, and the driver passed all sections of functional testing.The driver performed as intended with no evidence of a device malfunction.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) 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: 7474167
• MDR Text Key: 106976574
• Report Number: 3003761017-2018-00144
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121(21)
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

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: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR