MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION ADULT FLOW PROBE ¿ 3/8¿; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	102957
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
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 flows were noted to drop below the set alarm parameters.The centrimag system did not produce a "flow below minimum" audio or visual alarm.The patient was assessed and noted to be stable.The flow probe was tested by removal from the circuit.The "flow signal interrupted" alarm was activated.The flow probe sensitivity was set to "sensitive".Low flow limit briefly raised above current flow to test alarm - the "flow below minimum" alarm was activated.

• Brand Name: CENTRIMAG 1ST GENERATION ADULT FLOW PROBE ¿ 3/8¿
• 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: 24981567
• Report Number: 3003306248-2026-00184
• Device Sequence Number: 18764607
• Product Code: DWA
• UDI-Device Identifier: 07640135140139
• UDI-Public: (01)07640135140139
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 102957
• Device Catalogue Number: 102957
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 4 MO
• Patient Sex: Male