MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number	201-20003
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump was not seated properly in the motor.They moved the pump to backup motor and resumed support.The event was resolved by switching the pump to a backup motor.No products were exchanged and no products are returning to abbott.The pump worked as intended on the patient once seated in the new pump and is still active on the patient.
Additional Manufacturer Narrative
Section a: patient information not provided.No further information was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the centrimag pump not being seated properly in the centrimag motor was unable to be confirmed through this evaluation as no product or images were available, and a specific cause for the reported event could not be conclusively determined.The patient reportedly remained ongoing on the centrimag pump as of on (b)(6) 2026.Review of the device history record (dhr) for the centrimag blood pump, lot#: l08223-la6, revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) is currently available.The ifu provides the following warnings and cautions: ifu warning #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #8: ensure the pump is properly locked into the motor per the instructions for use supplied with the motor.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The section titled ¿pump setup and operation¿ provides instructions for how to mount the blood pump on the motor.The following instructions are provided: to mount the pump on the motor, remove the pump from the inner tray and insert the pump into the motor receptacle.Place the bottom of the pump into the motor receptacle with the outlet port positioned in the large groove.Match the grooves on the periphery of the pump with the fittings on the motor receptacle.Rotate the pump counterclockwise until the pump locks securely into place.Thread the retaining screw clockwise to secure in place.The pump must be fully seated into the receptacle to function properly.The section titled ¿emergency back-up equipment¿ states that a backup sterile pump and supplies to prime must be available.The ifu also contains a section titled emergency pump replacement.The current revisions of the ifu can also be found on the electronic ifu (eifu) page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CMAG BLOOD PUMP
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 24520812
• Report Number: 3003306248-2026-00136
• Device Sequence Number: 9759141
• Product Code: QNR
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: Lay User/Patient
• Device Expiration Date: 07/17/2026
• Device Model Number: 201-20003
• Device Catalogue Number: 201-20003
• Device Lot Number: L08223-LA6
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q325-HF-2
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 81 KG