MAUDE Adverse Event Report: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number L201-90411

Device Problem Communication or Transmission Problem (2896)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

It was reported that during maintenance of the centrimag console, it was observed that the data logger of the test monitor connected to the console would not display any data.The monitor was stuck on the ¿loading data¿ screen.Also, it was observed that the test monitor would occasionally reboot while connected to the centrimag console.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of the centrimag console not displaying data on its screen nor on the monitor, and the monitor occasionally rebooting while the console was in use, were confirmed.The returned centrimag console was received at the service depot where the reported events were reproduced while the console was in use alongside known working test equipment.The unit was troubleshot, and its interface device printed circuit board (ifd pcb) was found to be the cause of the issue.The board was replaced with a new component, resolving the issues.Then, the console was functionally tested and was found to perform as intended.A log file was unable to be retrieved from the centrimag console at the service depot due to the observed issue on the ifd pcb.After the ifd pcb had been replaced, no relevant data was available.The serviced and repaired console was returned to the customer site after passing all tests per procedure.The original ifd pcb was forwarded to the ppe department for further analysis.The board was placed within a known working test centrimag console.The console¿s screen did not display information while the board was in use, and test centrimag monitor was stuck on the ¿loading data¿ screen while occasionally rebooting.The board was troubleshot; however, no atypical findings were observed on the board¿s components.After troubleshooting, the board was placed back within the test console and operated as intended.The board was taken out and placed back in the console multiple times, and the console was restarted multiple times, and the board continued to function as intended at this point.Due to the intermittent nature of the event, the root cause of the board¿s issue was unable to be conclusively determined.Review of the device history record for centrimag 2nd gen.Primary console showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual provides information regarding emergencies/troubleshooting in section 10.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 instructs users to have the centrimag console¿s internal battery replaced every two years.Users are instructed to contact abbott for assistance in replacing the battery, as users may not replace the internal battery without proper training or assistance.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• MDR Report Key: 15839726
• MDR Text Key: 307830137
• Report Number: 3003306248-2022-14517
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6165184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• 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