MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90411

Device Problem Unexpected Shutdown (4019)

Patient Problems Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A final report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient was on veno-venous extracorporeal membrane oxygenation (ecmo).During circuit check the ecmo alarm sounded and displayed 0 rotations per minute (rpm) and 0 flow.The patient's heartrate dropped to the 40's and oxygen saturation dropped to 50's.There was no loss of consciousness and the emergency ventilator settings were initiates and the back up console employed to restore the speed and flow.The patient's vitals recovered.There was no patient injury and patient continued to be treated with backup unit.There was a potential loose cable between the centrimag main unit and the motor that could have caused the stoppage.The customer was to connect to mock loop to test the system.The nurse who performed the exchange stated the connection was tight and had to really pull to disconnect it.The patient had a transient change in vital signs and master oxygen saturation but returned to baseline as soon as returned to support.The patient was transferred while on cardiohelp device awaiting lung transplant.Related manufacturer reference report # 3003306248-2022-00034; 3003306248-2022-00035.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: damaged front overlay.The reported event of a motor stop was confirmed via the log file; however, the reported event of a loose cable between the console and motor was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review with events spanning approximately 3 days (17feb2022 ¿ 18feb2022, 23mar2022 per time stamp).The events occurring on 23mar2022 took place during lab testing at abbott.On (b)(6) 2022 at 14:01, a sub-fault ¿sf_ifd_shutdown_detected¿ activated and was followed by ¿motor disconnected: m2¿ and ¿flow below minimum: f3¿ alarms.The speed drop to 0 rpm with a flow slightly above 0 lpm.The alarms were able to be muted and cleared and the speed and flow recovered a couple minutes later.The console was powered off shortly after at 14:17.There were no other notable events active in the log file.The centrimag 2nd generation primary console was returned for analysis to the service depot and the reported event was unable to be reproduced.The console was tested with the returned and associated motor and was run for several days on a test loop.No alarms were observed.A full functional test was performed, and the unit passed all tests.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction.".The 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support.".No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13869101
• MDR Text Key: 290543911
• Report Number: 3003306248-2022-00033
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 8032780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 104 KG