MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE

Model Number	102953
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the centrimag pump motors was making a loud noise while running.This was noticed while doing daily checks.This was not being used on a patient.The nurse moved the equipment to biomed and they called the abbott service line.
Additional Manufacturer Narrative
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
This was said to be taken care of and was back in service.There was no patient involvement as it happened in a wet lab.
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported noise was unable to be confirmed through this evaluation, and a specific cause for the event could not be conclusively determined.Multiple requests for additional information regarding this event were submitted to the account; however, no response has been received at this time.The centrimag pump was not returned for evaluation.The lot number of the centrimag pump was not reported.The centrimag blood pump instructions for use (ifu) is currently available.This ifu also 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.Confirm that no red spot close to the levers is visible.The pump must be fully seated in the receptacle to function properly.The section titled ¿emergency backup equipment¿ states that a backup sterile pump and supplies to prime must be available.The current revisions of the instructions for use (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: CENTRIMAG BLOOD PUMP
• Common Device Name: BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE
• 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: 22520763
• Report Number: 3003306248-2025-00217
• Device Sequence Number: 18301117
• Product Code: QNR
• UDI-Device Identifier: 07640135140627
• UDI-Public: (01)07640135140627
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 11/14/2025

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: 102953
• Device Catalogue Number: 102953
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 09/23/2025; 11/12/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/17/2025; 10/22/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown