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

Model Number L201-90421

Device Problems Display or Visual Feedback Problem (1184); Fracture (1260)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported that the centrimag console monitor screen was smashed.The device was exchanged for the backup console and the patient was not affected.

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

Additional information communicated that when the centrimag console was removed from the centrimag system it was observed that the console screen was blank.While in the operating room, the console screen did not turn on despite being plugged into a power outlet.The centrimag motor was then replaced for safety reasons.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console screen being damaged was confirmed via analysis of the returned unit.The returned centrimag console (serial number: (b)(6) was evaluated by service depot.The returned centrimag console was evaluated by service depot, alongside known working test centrimag equipment.Visual inspection of the returned centrimag console revealed that the screen on the user interface was cracked.Upon powering on the console, it was observed that no information would display on the screen.The unit was disassembled to inspect the internal components, revealing that the screen on the screen print circuit board (pcb) was cracked.Damage to this component would result in the reported event.The damaged screen pcb was replaced with a new part and was then functionally tested, and no issues were observed.The serviced and repaired unit was returned to the customer site after passing all tests per procedure.A log file was downloaded from the returned centrimag console.The data in the log file did not indicate any issues with the centrimag console.No atypical events were observed within the timeframe of the reported event date of 30aug2023.The root cause of the damage could not be conclusively determined through this analysis.The device history records were reviewed, and the records revealed that the centrimag console, serial number (b)(6), was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 9 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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 8.3 ¿ ¿recommended preventive maintenance¿ instructs users to regularly inspect the console for signs of damage and to return the console back to thoratec for servicing if any damage is observed.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE, CAN
• 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: 17747498
• MDR Text Key: 323473802
• Report Number: 3003306248-2023-05070
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: L201-90421
• Device Lot Number: 6512449
• 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: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2018
• 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