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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

It was reported that the patient was on extracorporeal membrane oxygenation (ecmo) while in the operating room.Just before transfer to the intensive therapy unit (itu), the cart was unplugged from the mains.There was an immediate s3 error on the console which could not be cleared.There was no issue or change in flow, but it was decided to swap to a new console, motor, and flow probe.Related manufacturer's report number for the motor: 3003306248-2022-14524.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag 2nd generation primary console (serial #: (b)(6)) was returned for evaluation with the reported event of a s3 alarm and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 12 days ((b)(6) 2022 ¿ (b)(6) 2022, (b)(6) 2022, (b)(6) 2022 ¿ (b)(6) 2022, (b)(6) 2022 ¿ (b)(6) 2022, (b)(6) 2022 ¿ (b)(6) 2022, (b)(6) 2023 per time stamp).Events occurring on (b)(6) 2023 took place during testing at abbott.Beginning on (b)(6) 2022 at 20:50 a sub-fault ¿sf_lmc_motor_iic¿ activated and triggered a ¿system alert: s3¿ alarm.Pump operation was not interrupted.This alarm was able to be muted and cleared but continued to reactivate.The console was powered off on (b)(6) 2022 at 21:45.There were no other notable events active in the log file.The centrimag 2nd generation primary console was returned for analysis to the european distribution center (edc).The reported event was unable to be reproduced during functional testing.The reported event of a s3 alarm could not be correlated to an issue with the returned console due to the alarm being reproduced and isolated to the returned centrimag motor during testing of the motor (reference mfr # 3003306248-2022-14524).As an incidental finding, there was a vibrating noise from fan.The device history records were reviewed for the centrimag 2nd generation primary console and the console was found to pass all manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual (rev.M) 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 (rev.M) 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 (rev.M) table 13 entitled ¿console alarms & alerts¿ states how to properly interpret and troubleshoot all system alarms including s3 alarms.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag 2nd generation primary console (serial #: (b)(6)) was returned for evaluation with the reported event of a s3 alarm and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 12 days ((b)(6) 2022, (b)(6) 2023 per time stamp).Events occurring on (b)(6) 2023 took place during testing at abbott.Beginning on (b)(6) 2022 at 20:50 a sub-fault ¿sf_lmc_motor_iic¿ activated and triggered a ¿system alert: s3¿ alarm.Pump operation was not interrupted.This alarm was able to be muted and cleared but continued to reactivate.The console was powered off on (b)(6) 2022 at 21:45.There were no other notable events active in the log file.The centrimag 2nd generation primary console was returned for analysis to the european distribution center (edc).The reported event was unable to be reproduced during functional testing.The reported event of a s3 alarm could not be correlated to an issue with the returned console due to the alarm being reproduced and isolated to the returned centrimag motor during testing of the motor (reference mfr # 3003306248-2022-14524).As an incidental finding, there was a vibrating noise from fan.The device history records were reviewed for the centrimag 2nd generation primary console and the console was found to pass all manufacturing and quality assurance 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." the 2nd generation centrimag system operating manual table 13 entitled ¿console alarms & alerts¿ states how to properly interpret and troubleshoot all system alarms including s3 alarms.The 2nd generation centrimag system operating manual table 15 entitled ¿console maintenance schedule¿ states to replace the battery every 2 years.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: 16017829
• MDR Text Key: 308188288
• Report Number: 3003306248-2022-14523
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: 102954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2010
• 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