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

Model Number 201-90411

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer¿s report 2916596-2020-03465.It was reported that the centrimag alarm noted set pump speed not reached.The console screen was blank and the site was unable to clear the alarm.The rpms dropped to 3000-3200 while the flow read blank.The site switched to a backup console at this time, patient's mean arterial pressure (map) dropped to 40's which recovered when back on flow.

Event Description

Related manufacturer¿s report mfr-2916596-2020-03829, mfr- 2916596-2020-03465.It was reported that the centrimag alarm noted set pump speed not reached.The console screen was blank and the site was unable to clear the alarm.The rpms dropped to 3000-3200 while the flow read blank.The site switched to a backup console on (b)(6) 2020, patient's mean arterial pressure (map) dropped to 40's which recovered when back on flow.When the problem occurred again on (b)(6) 2020, the site changed out the motor and the console.The site communicated that the motor reportedly felt hot to the touch and they didn't have any issues following the device exchange.

Manufacturer Narrative

Section d4: correction - serial number is unknown.Section b3: correction- one console exchanged (b)(6) 2020 and another on (b)(6) 2020 but unknown which one is which date.This report is to report one of the console exchanges.The other console exchange is reported in mfr report #2916596-2020-03829 and the motor exchange is reported in mfr report #2916596-2020-03465.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a ¿set pump speed not reached: m5¿ alarm, console screen going blank, rpms dropping to ~3200 rpm and flow blanking was confirmed via the log file.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 17 days.The console was operating a motor at a speed of ~4000 rpm with a flow of ~4.5 lpm.On (b)(6) 2020 at 02:33:00, a sub_fault ¿sf_ifd_shutdown_detected¿ activated and triggered a ¿system alert: s3¿ alarm.A ¿set pump speed not reached: m5¿ activated at the same time stamp, and at 02:40:00 a ¿flow signal interrupted: f2¿ activated.The motor speed dropped to ~3300 rpm and the flow dropped to 0 lpm.There were no other notable alarms active in the log file.The console was returned for analysis to the service depot and was evaluated and tested under work order # (b)(4).The reported event was unable to be duplicated or verified.The console was tested with the returned and associated motor and a test flow probe.The console was run for an extended period of time, including overnights, and there were no disruptions at any point in rpms and flow levels.There were no alarms active.The console screen did not turn blank at any point.A full functional checkout was performed, and the unit passed all tests.The console was returned to the customer site.Additional provided information communicated on 03sep2020 stated that the wrong device was sent back in error.The devices that should have been returned are as follows: centrimag motor (serial #: (b)(6) and centrimag console (serial #: (b)(6).The root cause for the reported event was unable to be conclusively determined through this analysis.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.The device history records were reviewed for the 2nd generation primary console (serial #: (b)(6) and the console was found to pass all manufacturing and qa specifications.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
• MDR Report Key: 10252332
• MDR Text Key: 198385799
• Report Number: 2916596-2020-03466
• Device Sequence Number: 1
• Product Code: DWA
• 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
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CENTRIMAG MOTOR, US; CENTRIMAG MOTOR, US