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	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the there was a pixelation on half of the lcd screen on the centrimag console.It was intended to return for evaluation.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the centrimag console¿s screen not functioning as intended was not confirmed.The centrimag console (serial number (b)(6) was not returned for analysis.Questions regarding the event were asked multiple times and no responses were received.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.M) section 4 "warnings and 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." no further information was provided.The manufacturer is closing the file on this event.

• 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 ; +1(781)852-8207
• MDR Report Key: 50813030
• Report Number: 3003306248-2026-00301
• Device Sequence Number: 10680657
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: (01)07640135140702(10)10012697
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 10012697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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