MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problem Unexpected Shutdown (4019)

Patient Problems Cardiac Arrest (1762); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2020

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

Centrimag motor failure was reported.As the nurse was adjusting gas settings the stack monitor alarmed multiple times with one of the messages being "motor disconnected." afterwards, the centrimag console screen had gone blank, and the motor stopped revving.Motor was exchanged.

Manufacturer Narrative

Updated manufacturer's investigation conclusion: the reported event of a motor disconnect alarm, followed by the system stopping, was confirmed via the log file extracted from the returned centrimag console (serial number: (b)(6) during testing.On (b)(6) 2020, the system was observed to be operating around 4300 rpm / 5.8 lpm.At 15:54 on this date, a system shutdown was observed to have been initiated.Within the same minute, an m2: motor disconnected alarm and an m4: motor alarm, correlating to sub-fault ¿sf_lmc_levitation,¿ was observed, indicating a potential issue with the motor.At 15:58, the system¿s set rpm speeds were observed to have been set multiple times, to 800 and 1300 rpm, and the motor would briefly operate at these speeds before falling to 0 rpm within the same minute.Several more m2 and m4 alarms, with intermittently associated s3: system fault alarms, were observed throughout the remainder of the data, as well as events where the motor would stop running at a low set pump speed.The system was observed to have been shut down on (b)(6) 2020 at 18:26 and was not observed to be in patient use throughout the remainder of the log file.Incidental findings of alarm m6: motor over temp alarm observed within the log file.Information from the event date, on (b)(6) 2020, was unable to be observed within the log file, as the earliest available timestamp was on (b)(6) 2020.The returned centrimag motor (serial number: (b)(6) was tested at the european distribution center on 01mar2021.The motor was tested alongside known working test equipment; however, atypical events were unable to be reproduced throughout all testing.Although the motor operated as intended throughout testing, the motor was scrapped due to the reported event being observed within the log file.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag motor, serial number: (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 3 ¿about the 2nd generation centrimag primary console 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 8 entitled "emergency / 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 centrimag motor ifu in section titled "warnings," indicates that the motor may feel warm to the touch.Overheating is confirmed by a motor over temp console alert message and temperature sufficient to prevent the user from placing and holding a hand on the motor housing.Clamp the return tubing and switch to the backup system.The 2nd generation centrimag system operating manual section 10.1 entitled "appendix i ¿ 2nd generation centrimag 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.

Event Description

Related manufacturer report number: 3003306248-2020-06197.

Manufacturer Narrative

This event occurred at (b)(6).Manufacturer's investigation conclusion: the reported event of a motor disconnect alarm, followed by the system stopping, was confirmed via the log file extracted from the returned centrimag console (serial number (b)(6)) during testing.On (b)(6) 2020, the system was observed to be operating around 4300 rpm / 5.8 lpm.At 15:54 on this date, a system shutdown was observed to have been initiated.Within the same minute, an m2: motor disconnected alarm and an m4: motor alarm, correlating to sub-fault ¿sf_lmc_levitation,¿ was observed, indicating a potential issue with the motor.At 15:58, the system¿s set rpm speeds were observed to have been set multiple times, to 800 and 1300 rpm, and the motor would briefly operate at these speeds before falling to 0 rpm within the same minute.Several more m2 and m4 alarms, with intermittently associated s3: system fault alarms, were observed throughout the remainder of the data, as well as events where the motor would stop running at a low set pump speed.The system was observed to have been shut down on (b)(6) 2020 at 18:26 and was not observed to be in patient use throughout the remainder of the log file.During the investigation there was an incidental finding of m6: motor over temp alarm observed within the log file.The returned centrimag motor (serial number (b)(6)) was tested at the european distribution center on 01mar2021.The motor was tested alongside known working test equipment; however, atypical events were unable to be reproduced throughout all testing.Although the motor operated as intended throughout testing, the motor was scrapped due to the reported event being observed within the log file.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag motor, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 3 ¿about the 2nd generation centrimag primary console 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 8 entitled "emergency / 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 centrimag motor instructions for use (ifu), in section titled "warnings," indicates that the motor may feel warm to the touch.Overheating is confirmed by a motor over temp console alert message and temperature sufficient to prevent the user from placing and holding a hand on the motor housing.Clamp the return tubing and switch to the backup system.The 2nd generation centrimag system operating manual section 10.1 entitled "appendix i ¿ 2nd generation centrimag 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.

Event Description

It was reported that the motor failure was a significant event which resulted in the patient having a cardiac arrest, 3 rounds of cpr and adrenaline until the motor was changed and ecmo (extracorporeal membrane oxygenation) was re-established.No additional information was provided.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 11021389
• MDR Text Key: 222836107
• Report Number: 3003306248-2020-06198
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE.
• Patient Outcome(s): Life Threatening