MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

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

It was reported that during routine 6-month battery maintenance of centrimag system, the field service engineer tried to enter the bios but battery maintenance was idle and system alert s3 alarm displayed.The error message did not disappear even after the alarm acknowledge button was pressed.The issue did not resolve after exchanging the battery.The centrimag console will be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of battery maintenance being idle and a s3 alarm was confirmed via the customer submitted photo.The centrimag 2nd generation primary console (serial #: (b)(6)) was not returned for analysis.Multiple attempts were made to request the return of the item; however, the centrimag 2nd generation primary console has not been exported and the complaint will be reopened if it returns at a later date.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." the 2nd generation centrimag system operating manual table 13 entitled ¿alarms and alerts¿ addresses how to properly interpret and troubleshoot all system alarms.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of battery maintenance being idle was confirmed via the customer submitted photo, and the reported event of a s3 alarm was confirmed via the log file and testing.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 7 days ((b)(6) 2021, (b)(6) 2022 per time stamp).Events occurring on (b)(6) 2022 took place during lab testing at abbott.On (b)(6) 2021 at 07:40, a ¿system alert: s3¿ alarm activated following startup of the console.The alarm was accompanied by the sub-fault ¿sf_sps_fan_speed¿.This alarm was able to be muted.This alarm sequence occurred again on (b)(6) 2021 at 06:01, (b)(6) 2021 at 05:27, (b)(6) 2021 at 08:30 ¿ 09:31, and (b)(6) 2022 at 23:33.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis to the service depot.The console was connected to power and powered on.After booting up, a s3 alarm was present.The console was opened for an internal inspection, and the fan was observed to be damaged.It was determined that the damage fan was causing the s3 alarm to activate.The fan was replaced.A full functional test was performed, and the unit passed all tests.The console was returned to the customer.The root cause for the reported event was conclusively determined to be due to a damaged fan in the console.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." the 2nd generation centrimag system operating manual table 13 entitled ¿alarms and alerts¿ addresses 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.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: 12477833
• MDR Text Key: 278408323
• Report Number: 3003306248-2021-04035
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 201-90401
• Device Catalogue Number: 201-90411
• Device Lot Number: 8168919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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