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

Model Number 201-90411

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problems Hemorrhage/Bleeding (1888); No Information (3190)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer¿s report 2916596-2020-04413.It was reported that the site had 2 cases in a row where flow dropped off with 2 different sets of disposables.A rotaflow was used in its place with no issues so not a cannula issue, nor was clot found in any of the circuits.The disposables were disposed of.

Event Description

It was reported that the patient was in the operating room for a lung transplant.Once they were ready to perfuse the lungs the patient needed to go on extracorporeal membrane oxygenation (ecmo).Upon initial cannulation the femoral artery and aorta were dissected.This is the first time the circuit was used on the patient.The patient went back on bypass and the cmag circuit was thrown away because it was stagnant when the patient went back on bypass.When the patient was ready to go back on ecmo for a second time, they felt like the could not get adequate flow, the patient was bleeding and they were giving a lot of volume so they went back on bypass.There was also a lot of air in the circuit on the second go around.Once they were going on ecmo a third time they decided to just switch to a rotoflow device and everything went perfectly.The only alarms were low flow alarm setting and the intentional stopping and removing of the pumps.Related mfr # for motor: 2916596-2020-04413 reports for products associated with the other ecmo circuit were reported under: related mfr # for motor: 3003306248-2020-00079 related mfr # for console: 3003306248-2020-00080 related mfr # for flow probe: 3003306248-2020-00081 related mfr # for blood pump: 3003306248-2020-00082.

Manufacturer Narrative

Reference to mfr.Report #s 3003306248-2020-00079, 3003306248-2020-00080, 3003306248-2020-00081, and 3003306248-2020-00082 in previous report were unrelated.This patient is separate from the lung transplant event and was actually in hospital as an extracorporeal cardiopulmonary resuscitation patient that was on transport to the operating room for a fasciotomy.On 07jan2021 the product investigation was completed.A supplemental report was sent 20jan2021 with aware date 19jan2021.This report is correcting g4 to be 07jan2021.Additionally, information in h10 was incomplete and should have included: the reported event of a flow reading issue was confirmed via a log file extracted from the centrimag console during testing.Data from the event date, (b)(6) 2020, was not observed within the log file.On (b)(6) 2020 at 7:50, the system¿s speed was observed to ramp up from 1200 rpm to 2700 rpm; however, flow reading remained at 0 lpm.No atypical alarms were associated with these events.The system was manually shut down approximately 2 minutes later and did not appear to be in patient use throughout the remainder of the log file.No other notable events were observed within the timeframe of the reported event.The returned centrimag console (serial number (b)(6) ) was functionally tested on 22sep2020 and was found to perform as intended.Rpm speeds and lpm levels remained consistent throughout all testing.A full functional checkout was performed, and the 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.10) 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 (\rev.10) section 12.1 entitled "appendix i ¿ primary 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 centrimag 2nd gen.Primary 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
• MDR Report Key: 10513693
• MDR Text Key: 206353455
• Report Number: 2916596-2020-04412
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6832584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, US; CENTRIMAG MOTOR, US.