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

Catalog Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The freedom driver was not supporting a patient.The customer reported that the freedom driver displays a large flow discrepancy.The driver display reads 7.5 and the 50cc flow meter reads 6.1.This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.In addition, it would not prevent the driver from performing 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.

Event Description

The freedom driver was not supporting a patient.The customer reported that the freedom driver displays a large flow discrepancy.The driver display reads 7.5 and the flow meter on a patient simulator with a 50cc tah-t reads 6.1.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external and internal components revealed no anomalies.Review of the alarm history did not reveal any new permanent fault alarms since the driver was last serviced.During investigation testing, the reported difference in co readings between the freedom driver display and the patient simulator flow meter was not reproduced.The investigation determined that the freedom driver performed as intended, and there was no evidence of a device malfunction.The driver was serviced and passed all final performance testing.The freedom driver system test protocol in the freedom driver system operator manual instructs the customer to test freedom drivers upon receipt and prior to patient use by connecting them to a patient simulator with a 70cc tah-t, set to defined normotensive settings.The test protocol instructs the customer to confirm only that the co on the driver display is within 4.9 and 9.7 liters per minute.The co comparison described by the customer (testing the freedom driver on a patient simulator with a 50cc tah-t) is not a part of the freedom driver system test protocol.Syncardia clinical support contacted the clinical staff at the hospital to assist them to understand the appropriate testing and the expected outcomes of the testing that is recommended in the freedom driver system operator manual.The reported issue posed a low risk to a patient because it was observed when the freedom driver was not supporting a patient.In addition, the cardiac output reading on the flow meter of the patient simulator at the hospital is to be used as a reference to help test the freedom driver.This issue would not have prevented the freedom driver from performing its life-sustaining functions.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5563786
• MDR Text Key: 42916422
• Report Number: 3003761017-2016-00138
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2012
• 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