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 Electrical /Electronic Property Problem (1198)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It was reported that a b1 alarm occurred while a representative was performing maintenance on the centrimag console's battery.The representative was unable to perform a battery maintenance test due to the alarm.The console was removed from service.

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Correction: the initial report was inadvertently submitted with a cfn-based manufacturer report (mfr) number: 2916596-2023-xxxxx.The mfr number should have been fei-based with the 10-digit fei being (b)(4).Manufacturer's investigation conclusion: the reported event of a b1 alarm active on the centrimag console was confirmed.The centrimag console (serial number (b)(6)) was returned and evaluated at the european distribution center (edc) and a log file was downloaded.The downloaded log file contained events spanning approximately 9 days ((b)(6) 2023 ¿ (b)(6) 2023, (b)(6) 2023, (b)(6) 2023, and (b)(6) 2023 per the timestamp).Data captured on (b)(6) 2023 is consistent with data captured while the console was returned to the edc.Throughout the log file, the console was operating a motor at a speed of between 0 rpm and approximately 3500 rpm.The flow operated at approximately 5 liters per minute when the pump was on.The log file captured an intermittent atypical b1 alarm active on (b)(6) 2023 and on (b)(6) 2023 at 11:23:21 due to a sf_sps_battery_selftest sub fault flag.The alarm was muted each time it was active and did not clear on its own.Pump speed remained at 0 rpm while the b1 alarm was active.During the evaluation, the console was connected to a mock circulatory loop for an extended period of time and a b1 alarm was active, confirming the reported event.The unit was then forwarded to product performance engineering (ppe) for further analysis.During ppe analysis the unit was placed on a mock circulatory loop and the b1 was active.The alarm did not affect functionality of the unit as the system was able to maintain set pump speed.The console was disassembled to reveal that the internal components were in unremarkable physical condition.No additional troubleshooting could be completed due to the unit being version 1.Version 1 consoles have been obsoleted and are incompatible with our test fixtures.The root cause of the reported event could not be conclusively determined through this analysis; however, electrically compromised components on the battery charger printed circuit board could have contributed to the event.Review of the device history record for the centrimag 2nd generation primary console , serial number (b)(6) , showed the device was manufactured in accordance with manufacturing and quality assurance (qa) specifications.The 2nd generation centrimag system operating manual (rev.C) 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 (rev.C) 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." 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: 17374347
• MDR Text Key: 320243123
• Report Number: 2916596-2023-05266
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90401
• Device Lot Number: 6576101
• 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: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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