MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30105

Device Problems Calibration Problem (2890); Infusion or Flow Problem (2964)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Patient information was requested, information not yet available.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 centrimag patient was getting a computed tomography (ct) scan and after moving back onto their bed, the flow on the centrimag console was not reading a numerical flow, just three dashes.The circuit was examined for kinks, but no obvious kinks were found.Blood flow was confirmed by shining a light on the tubing and checking the motor/pump head for blood flow movement, which confirmed that there was blood flow.The flow sensor was verified to be positioned properly and fully closed.Flow probe connection to the console was verified to be tightly inserted in the centrimag.Despite these steps, no numerical flow reading was achieved.The patient's mean arterial pressure (map) had decreased from 66 to 58 and was holding steady at ~50mmhg, but they had also received a propofol bolus for moving on the ct table, and it was not decreasing.An additional specialist evaluated the situation and was concerned about a flow probe malfunction.The pump head then intermittently made a loud vibratory noise.It was thought that possibly it wasn't seated properly, so the specialists verified that the pump head was "seated" correctly in the motor.The noise from the pump head started to become more frequent but the patient still had stable vital signs.The patient was quickly returned to the cardiac care unit as the pump head began visibly vibrating.The flow, as measured from an ancillary extracorporeal membrane oxygenation (ecmo) device, was significantly reduced.Another flow probe from a non-abbott device was placed onto the centrimag circuit to confirm flow.The decision was made to change the circuit and console/motor system.The changeout was uneventful.The console and pump head were secure for return to abbott.Several hours later in the morning, it was noted that the pump head had a large clot surrounding ~1/4 to 1/3 of the actual pump head "vanes".Related mfr: 2916596-2024-00240.Related mfr: 2916596-2024-00241.Related mfr: 2916596-2024-00242.

Manufacturer Narrative

Correction: the initial report was incorrectly submitted with a cfn-based manufacturer report (mfr) number: 2916596-2024-00652.The mfr number should have been fei-based with the 10-digit fei being 3003306248.Manufacturer's investigation conclusion: the centrimag flow probe was returned for evaluation following the reported event of the centrimag console screen showing a blank flow; however, it was determined that the flow probe was unrelated to the cause of the reported event.The returned centrimag flow probe (serial number: (b)(6) was evaluated by service depot alongside the returned centrimag console (serial number: (b)(6) and known working test centrimag equipment for several days without any issues or atypical alarms produced.A full functional checkout was performed, and the unit passed all steps of the test without any issues.The serviced and tested centrimag flow probe was returned to the customer site after passing all tests per procedure.A log file was downloaded from the returned centrimag console.The data in the log file did not indicate any issues with the centrimag flow probe.It was revealed that the root cause of the reported event was related to the returned centrimag console and the centrimag motor.Further analysis of the log files associated with this event have been addressed via the console and motor investigations.The reported event could not be correlated to an issue with the returned centrimag flow probe.The device history records were reviewed, and the records revealed that the centrimag flow probe, serial number (b)(6) , was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual (rev.M) section 10 ¿ ¿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 (rev.M) section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), 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: EM-TEC ADULT FLOW PROBE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18596359
• MDR Text Key: 335084033
• Report Number: 2916596-2024-00652
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: (01)07640135140108(10)8039013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-30105
• Device Lot Number: 8039013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 99 KG