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

Model Number 201-90411

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag unit was not displaying the flow reading.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console not displaying the flow reading was confirmed via analysis of the log file downloaded from the returned centrimag console (serial number: (b)(6).Prior to the reported event date of (b)(6) 2021, the system was observed to be operating the pump at the set speed without any issues.On (b)(6) 2021 at 08:19, a s3 alarm activated correlating to a can bus send error sub-fault.The flow reading was observed to be 0 lpm at this time due to this sub-fault.The motor was observed to be disconnected at this time while operating the patient at approximately 1300 rpm, causing the speed to drop to 0 rpm.The motor was then observed to be reconnected within the same minute and the pump ramped up to the set speed; however, the flow reading remained at 0 lpm, and several f2: flow signal interrupted alarms were intermittently observed while the system remained in use, both due to the can bus sub-fault.The s3 alarm was also observed to be muted within the same minute but was not cleared.On (b)(6) 2021 at 08:31, the system was observed to have been powered on and off.This appears to have resolved the issue, as once the system powered back on the flow reading was observed to be approximately 4.3 lpm.The system was observed to be manually shut down on (b)(6) 2021 at 10:26 and was not observed to be in patient for the remainder of the log file.The returned centrimag console was tested by service depot with known working test centrimag equipment, and the console functioned as intended without any issues or atypical alarms produced.The serviced and tested unit was returned to the customer site after passing all tests per procedure.The root cause of the observed can bus sub fault, resulting in the reported events, could not be conclusively determined through this analysis.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual (rev.11) section 10 ¿ ¿emergency/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 (rev.11) section 12.1 ¿ "appendix i ¿ console alarms and alerts" cover all alarms (auditory and visual), including system alarms, and the appropriate actions to take if the issue does not resolve.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 qa specifications.The centrimag console was shipped to the customer on 23jun2015.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
• MDR Report Key: 12379055
• MDR Text Key: 268526131
• Report Number: 3003306248-2021-04020
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• 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: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1