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

Model Number 201-90421

Device Problem Infusion or Flow Problem (2964)

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

Event Date 08/16/2021

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

It was reported that on (b)(6) 2021 a patient who had been on centrimag extracorporeal membrane oxygenation (ecmo) for several weeks had the flow signal drop off over the past several days activating "flow signal interrupted" alarms and the mag monitor displayed dashes.The flow probe had been moved regularly as recommended and it had always been on arterial line returning blood to the patient and located after the oxygenator.The centrimag system was believed to be flowing as the lines had a color differential and that the patient's saturation was acceptable.Another centrimag console and flow probe were brought in but they also failed to read a flow.The flow probe was replaced but the new one still could not read a flow.The flow probe was then moved to the venous line of the veno-venous circuit to which a flow was displayed.The displayed flow was appropriate for the 4800 rpm that was being used to support the patient.The perfusionist checked the male pins on the flow probe connector (all looked appropriate), changed the flow sensitivity from normal to fine, placed he flow probe backwards on the venous line to demonstrate that the system was detecting flow against the arrowed direction and displayed down arrows as it should, and changed the flow recorder speed from slow (2mins) to fast (20 secs).The perfusionist examined one of the drainage lines and thought there was a possible issue with patient positioning of the cannula.The flow display kept dropping out and the pump made an odd sound.The trace itself was very unstable and resetting the flow probe connection had worked on 3 occasions to resolve this.To troubleshoot the issue the flow connection was reset, the flow sensor was moved to the tubing on the arterial side, the tubing was cleaned, the circuit was checked for air, the flow probe was moved to the pump inflow side (which had success), and finally the flow probe was moved back to the arterial side of the circuit and worked until the ecmo was disconnected.It was suspected that there was a potential thrombus or air embolus blocking the ultrasonic signal, but none was found.The present theory was that the flow was disrupted from the cannula and caused the pump noise.The flow probe display failure did not seem related to the pump noise and continued when the noise had ceased.The patient later passed away.No products had been exchanged nor were they returned to abbott.It was believed to be unlikely that there were patient harm from the equipment.Related manufacturer report numbers #3003306248-2021-04026 and # 3003306248-2021-04027.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a f2: flow signal interrupted alarm was not confirmed as the centrimag console (serial number: (b)(6)) was not returned for analysis, and no log files were submitted for review.Additional information stated that no products would be returned for analysis.The root cause of the reported event could not be conclusively determined through this analysis.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 2nd generation centrimag system operating manual section 8 ¿ ¿emergencies/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 ¿ "appendix i ¿ 2nd generation centrimag primary console alarms and alerts" cover all alarms (auditory and visual), including flow related alarms, and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH ADULT FLOW PROBE, CAN
• 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: 12432055
• MDR Text Key: 270076450
• Report Number: 3003306248-2021-04025
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: 07640135140672
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 201-90421
• Device Catalogue Number: 102954
• Device Lot Number: 6787952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2018
• 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