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

Model Number 201-90411

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

Specific patient information was requested but was not yet provided.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 nurse tried to turn the rotation per minutes (rpms) up to 5500 but was unable to go past 5300 as the rpms were fluctuating from 5200 to 5250.A decision was made to swap the motor and console but in the middle of picking up the attached console to arrange things, flows and rpms were lost and the motor and console had to be changed emergently.Given the emergent nature of the issue, no further troubleshooting was performed and the issue was not isolated to either of the devices.The associated alarm was unknown and it was said to be either m1 or m4.Both the motor and console were returned for evaluation.Related mfr: 3003306248-2022-12530.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console unable to go past 5300 rpm when attempting to reach 5500 rpm was not confirmed.The centrimag 2nd generation primary console (serial number: (b)(6) was returned and evaluated at the service depot on 03nov2022.During the evaluation, during the evaluation, the reported event of the console not being able to increase past 5300 rpms while attempting to reach 5500 rpms was not able to be reproduced.During testing, the console and motor were connected to a test loop and were run for several days.The console speed was set to 5500 rpms multiple times and was able to maintain the set speed without any alarms.The motor¿s cable was flexed throughout its entire length and no alarms were observed.Upon visual inspection of the motor cable, there were several kinks observed causing the motor to be suspect.The motor will be scrapped due to the observed kinks on its motor cable.This is addressed in the motor investigation.The console was visually observed, and a cut was observed on its front overlay.The front overlay of the console was replaced with a new working overlay which resolved the issue of the cut.The console was functionally tested and passed all tests.The console is ready for use and will be returned to the customer.There was no other troubleshooting performed due to the emergent nature of the issue, and the issue was not isolated to a certain product, the root cause of the reported event could not be conclusively determined through this analysis.Review of the device history record for the centrimag console, serial number: (b)(6), showed the console was manufactured in accordance with manufacturing and qa specifications.The console was shipped from abbott on 30jun2016.The 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.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, section 8 ¿system operations¿ instructs users on how to adjust the system¿s set speed by using the centrimag console¿s interface.Slowly increase the rpm until the flow rate is at the desired level.Section 6.7 ¿operator controls¿ also describes how to use the console¿s interface to adjust pump speed.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: 15691998
• MDR Text Key: 303303226
• Report Number: 3003306248-2022-12531
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 85 KG