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

Catalog Number 397002-001

Device Problems Invalid Sensing (2293); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Right Ventricular Failure (2055)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

The companion 2 driver has been 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 authorized distributor, reported that the companion 2 driver displayed a "major" discrepancy between the left and right filling volumes while supporting a patient.The customer also reported that "in order to avoid alarms of high filling volumes for the left ventricle, the clinicians had to decrease the right filling volumes, leading eventually to symptoms of right heart failure (high central venous pressure, edema, etc.)." the customer also reported that "it seems that the left filling volume sensor was out of range." the customer also reported that patient was subsequently switched to the backup companion 2 driver and the problem was solved; "the patient improved immediately and he is now doing perfectly fine.".

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.Review of the electronic patient file revealed discrepancies between the left and right fill volumes, as well as the cardiac output, thus confirming the customer experience.The driver was put on patient support on (b)(6) 2017.The multiple left fill volume high alarms were observed.On (b)(6) 2017, the customer made attempts to correct this imbalance and rectify the left fill volume high alarms by changing driver settings.The left fill volume high alarms were rectified, however, the discrepancy between the two sides remained and multiple right fill volume high alarms were then observed.There was a consistent difference between the left and right fill volumes as well as the cardiac output further confirming the customer experience.The customer-reported fill volume discrepancy was reproduced during investigation testing.The root cause of this issue was determined to be malfunctions of the left and right mass flow sensor cables.The cables were most likely damaged by wire ties, which were fastened too tightly during a driver service.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.(b)(4) follow-up report 1.

Event Description

The customer, a syncardia authorized distributor, reported that the companion 2 driver displayed a discrepancy between the left and right cardiac outputs while supporting a patient.The customer also reported that hospital staff "in order to avoid alarms of high filling volumes for the left ventricle, the clinicians had to decrease the right filling volumes, leading eventually to symptoms of right heart failure (high central venous pressure, edema, etc.)." the customer also reported that patient was subsequently switched to the backup companion 2 driver and the patient "improved immediately and he is now doing perfectly fine.".

• 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 Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6595181
• MDR Text Key: 76127214
• Report Number: 3003761017-2017-00072
• Device Sequence Number: 1
• Product Code: LOZ
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR