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

Model Number 201-90411

Device Problems Communication or Transmission Problem (2896); Infusion or Flow Problem (2964)

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

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is completed.

Event Description

It was reported that the patient came into the emergency department on (b)(6) 2022 with right coronary artery (rca) st elevation myocardial infarction (stemi).The patient was taken to the catheterization lab and a stent was placed to the rca.The patient was hemodynamically unstable resulting in balloon pump placement and transfer to the operating room (or).A coronary artery bypass graft (cabg) and mitral valve replacement (mvr) were performed.It was determined that the patient needed right ventricular (rv) support when attempting to separate from bypass.Pump priming was unremarkable and right ventricular assist device (rvad) support was slowly increased to about 4-6 liters per minute (lpm) with transition from bypass with no flow probe issues.At this point, the flow probe alarmed with no flow value displayed (was displayed as the flow value).This would occur for a few seconds before a flow value returned to the console.The surgeon could feel consistent flow when placing their hands on the tubing even when the console displayed intermittent dashes.No air was seen traveling through the pump circuit when this was occurring.The issue occurred continuously even with a different flow probe.It was determined that a console change was needed to fix the issue and the surgeon decided the patient needed venovenous extra corporeal membrane oxygenation (vv ecmo) support.The patient was transitioned to a new console.Related manufacturer's report regarding the motor: 3003306248-2022-11276.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of f2: flow signal interrupted alarms was confirmed via the log file extracted from the returned centrimag console (serial number (b)(6) ) during testing.The pump operated at ~3600 rpm on the reported event date of 02jun2022.Flow values were observed to range from approximately ~3.3 - ~5.0 lpm.Several f2: flow signal interrupted alarms were observed throughout the data beginning on 02jun2022 at 19:56; the alarms appeared to have activated due to the flow value fluctuating to 0 lpm, as the flow signal appeared to have intermittently lost communication with the system during these events.The system was observed to have been manually shut down at 20:15 on the same day, and no other notable events were observed.The returned centrimag console was functionally tested alongside the returned centrimag flow probe (serial number 65153, evaluated separately) at the service depot for an extended period and was found to perform as intended.Several known working test probes were also used alongside the console, and atypical events were unable to be reproduced throughout all testing.The service and tested console was returned to the customer site after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual (rev.M) provides information regarding emergency/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 (rev.M) section 12.1 entitled "appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including flow-related alarms, as well as appropriate operator response to these events.Review of the device history record for the centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.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
• 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: 14753639
• MDR Text Key: 302591005
• Report Number: 3003306248-2022-11277
• 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: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 125 KG