MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; Control, pump speed, cardiopulmonary bypass

Model Number	201-90411
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section g4: there was no patient involved in this event.The pma # provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the reported event of the centrimag console not passing functional checkout was confirmed via evaluation.The centrimag 2nd generation primary console (serial number (b)(6) was inspected at the service depot.During functional testing, the console did not withstand surge testing of up to 2.0 kilovolts (kv).The unit will be held by the service depot until parts become available for rework.The root cause for the reported event was determined to be due to the ac/ dc power supply.A corrective action was initiated for this issue, and this centrimag console was manufactured prior to the implementation of this corrective action.The device history records were reviewed for the centrimag 2nd generation console (serial #: (b)(6) and the console was found to pass all manufacturing and qa specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The 2nd generation centrimag system operating manual (rev.E) section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual, section 10 entitled "emergency and troubleshooting", states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual, section 12.4 ¿ "appendix iv ¿ electromagnetic immunity¿, covers the electromagnetic immunity tests, test levels, compliance levels, and electromagnetic environment guidance.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that during functional testing the console did not meet iec 61000-4-5 standards for surge testing.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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: 24258103
• Report Number: 3003306248-2026-00118
• Device Sequence Number: 7893970
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: (01)07640135140702(11)240506
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K131179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 10329487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q224-HF-2
• Patient Sequence Number: 1
• Patient Sex: Unknown