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

Model Number 201-90411

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that centrimag failed while attached to a patient.Monitor showed "usb removal' notice continuously for a few days which had to be cleared.Patient was switched over to a different device.A replacement / loaner was requested.Additional information was requested but not yet provided.

Manufacturer Narrative

Section d3: correction.

Manufacturer Narrative

Section a1, a2, a3, a4, b5: additional information.

Event Description

Additional information: the system simply stopped working, at which point no flow alarm went on.Upon change out to a different system (sorin) the ecmo was resumed with no issues.Patient was started on cmag on (b)(6) 2019.

Manufacturer Narrative

Section d3, g1, g2: correction.

Event Description

Related manufacturer report number: 2916596-2019-06056.

Manufacturer Narrative

Sections b5, d11: additional information manufacturer's investigation conclusion: the reported event of the system stopping was confirmed via the log file; however, the reported event of a no flow alarm was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(4) ) was returned for analysis and was tested under work order #54116153.The reported event was not able to be reproduced.The console was tested with a test monitor and the associated motor (serial #: l05333-0001), and flow probe (serial #: (b)(4) ).The console did not display any error codes or messages at any point.The console always functioned as intended.A full functional checkout was performed, and the unit passed all tests.The console was returned to the customer site.A log file was downloaded from the returned console.A review of the downloaded log file showed events spanning approximately 6 days ((b)(6)2019 ¿ (b)(6)2019 per time stamp).On (b)(6)2019 at 16:08.The sub fault ¿sf_ifd_shutdown_detected¿ activated and triggered a ¿system alert: s3¿ and ¿set pump speed not reached: m5¿.In the same time stamp, the sub fault ¿sf_lmc_levitation¿ activated and triggered a ¿motor alarm: m4¿ alarm.The flow dropped to 0 lpm and the motor speed fluctuated between 0 rpm and ~3800 rpm.The alarms were able to be muted and cleared.Although the root cause of the reported event could not be conclusively determined, reports of similar events have been documented and corrective action has been initiated to investigate the issue.This investigation determined that the root cause of the events captured in the log file was related to the motor used during the event.Action is being taken to address the issue and reports of similar events will continue to be tracked and monitored.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." the 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 9530884
• MDR Text Key: 173285268
• Report Number: 2916596-2019-06055
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/03/2020

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 Expiration Date: 12/31/2019
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6258803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/02/2020; 01/29/2020; 01/29/2020; 03/27/2020
• Supplement Dates FDA Received: 01/09/2020; 01/31/2020; 02/18/2020; 04/03/2020
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, US.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 77