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 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the full report.

Event Description

It was reported that a 2nd generation console had a blank lcd screen.The account planned to return the console for service.A loaner was to be sent until the console was repaired and returned.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a blank lcd screen was confirmed via the log file.The centrimag 2nd generation primary console was returned for analysis and a log file was downloaded for review with events spanning approximately 5 days (07feb2021 ¿ 08feb2021, 11feb2021 ¿ 12feb2021, 16feb2021 per time stamp).On (b)(6) 2021 at 10:36:01, a ¿sf_ifd_shutdown_detected¿ sub fault activated indicating that the console screen went blank.This triggered a system fault: s3 alarm at 10:36:04.The motor speed dropped to ~3000 rpm and the flow dropped to 0 lpm.A set pump speed not reach: m5 alarm activated at 10:36:07.At 10:36:40, the motor speed increased to ~3100 rpm; however, the flow remained at 0 lpm.At 10:37:38, a motor alarm: m4 activated.These three alarms were able to be muted.The speed remained at ~3100 rpm with a flow of 0 lpm until the console was powered down at 10:59:55.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis and the reported event of the blank lcd screen was not able to be confirmed.The console was run on a test loops for several days and no abnormal operation was observed.The console was functionally tested and passed all tests before returning to the customer.The root cause of 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 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 section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing 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: 11340018
• MDR Text Key: 232322952
• Report Number: 2916596-2021-00764
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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: 02/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1