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

Model Number L201-90411

Device Problem Infusion or Flow Problem (2964)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

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

It was reported that the centrimag (cmag) console rpms dropped to 0 rpm with low flow when the cmag motor was manipulated.The issues was repeatable.The console, motor and flow probe returned for investigation.Manufacturer report number of motor: 3003306248-2020-06199.Manufacturer report number of flow probe: 3003306248-2020-06541.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag console (serial number: (b)(6) ) was returned for evaluation following the reported event of the motor speed dropping to 0 rpm.However, it was determined that the returned centrimag console was unrelated to the cause of the event.The returned centrimag console was functionally tested and operated as intended throughout all testing.The serviced and tested unit was returned to the rental pool after passing all tests per procedure.It was revealed that the root cause of the reported event was related to the returned centrimag motor (serial number (b)(6) ).The motor¿s evaluation along with the log file associated with this event have been addressed via the motor¿s investigation.The device history records were reviewed for the centrimag console (serial number: (b)(6) ) and the records revealed that the console was manufactured in accordance with manufacturing and qa specifications.The centrimag console was shipped to the customer on 19jan2018.The 2nd generation centrimag system operating manual 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 section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including alarms related to the system stopping, 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.

Event Description

It was reported that the patient did not have an adverse event associated with the failure, the perfusionist switched out the console and drive.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT
• 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: 11135608
• MDR Text Key: 229154541
• Report Number: 3003306248-2020-06200
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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: L201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 5873032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG FLOW PROBE - 3/8", SN: (B)(6) ; CENTRIMAG MOTOR, SN: (B)(6)
• Patient Age: 42 YR
• Patient Weight: 91