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

Model Number	102953
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
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 reported that there was a grinding noise that came from the centrimag motor.There was a delay to start the pump due to the motor issue.
Additional Manufacturer Narrative
Corrected data: report type corrected to malfunction.Section b1: corrected to product problem.Section b2: corrected.Section d5: operator of device corrected.Section h1: corrected.Section h6: health effect - impact code corrected.Manufacturer's investigation conclusion: no device issues with the centrimag blood pump were reported or identified through this evaluation.The centrimag blood pump was not returned for analysis, and the cause of the grinding noise was isolated to an issue with the returned centrimag motor (evaluated separately under the motor evaluation).Review of the device history record (dhr) for the centrimag blood pump, lot number 10646449 / l08309-la5, revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) is currently available.Although no pump issues or adverse events were reported, the centrimag blood pump ifu provides a list of adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.The ifu cautions to always have a backup centrimag pump, console, motor, and accessories available for use.The current revisions of the instructions for use (ifu) and operation manual 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.
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22787210
• Report Number: 3003306248-2025-00233
• Device Sequence Number: 8236438
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: (01)07640135140627(10)10646449(17)270917
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: 10646449
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 09/23/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/24/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 17 KG