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

Model Number	L201-90411
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had an m4 alarm when utilizing one of their centrimag motors.The motor was replaced with a different one.
Additional Manufacturer Narrative
A1-a4: patient information not provided.Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was additionally reported that the alarm occurred during the setup and priming phase.There was no patient involvement.
Additional Manufacturer Narrative
D5 - operator of device: correction.Manufacturer's investigation conclusion: the reported event of a m4 alarm was not confirmed.Additional information provided communicated that products would be returned for analysis; however, to date no products have been returned.If any products are returned at a later date, this file will be reopened with further analysis.The root cause of the reported event could not be conclusively determined through this analysis.The serial number of the centrimag console was not provided with this event.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 motor 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.
Additional Manufacturer Narrative
Section g3: the previous report was submitted on 18nov2024 with a g3 date of nov 18, 2024.The correct g3 for the previous report should have been nov 15, 2024.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
G4: pma number corrected.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the centrimag console was evaluated following the reported event of a m4 alarm; however, it was determined that the console was unrelated to the caused of the reported event.Per the centrimag motor investigation, an improper solder connection was identified, which resulted in the reported event.The centrimag console was not returned for analysis.If the console is returned at a later date, this file will be reopened with further analysis.The reported event could not be correlated to an issue with the centrimag console.The serial number of the centrimag console was not provided with this event.The current revision of the operating manual instructions for use (ifu) can be found on the eifu page of the abbott website.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 system and motor 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 RENT
• Common Device Name: 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20050857
• Report Number: 3003306248-2024-04406
• Device Sequence Number: 7896173
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: (01)07640135140672
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K020271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: L201-90411
• Device Catalogue Number: L201-90411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 11/18/2024; 03/08/2025; 10/16/2025; 04/15/2026
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/16/2024; 11/18/2024; 04/01/2025; 10/31/2025; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown