MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	201-30105
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the centrimag flow probe was intermittently not recognized by the centrimag console which showed dashes.It also intermittently showed flow when there was no flow.
Additional Manufacturer Narrative
D4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.
Additional Manufacturer Narrative
D9: serial number, lot number, primary udi number, updated.H4: manufacture date, updated.Manufacturer's investigation conclusion: the reported event of the centrimag flow probe intermittently not being recognized by the console, and showing flow when there is no flow, was not confirmed.The flow probe (serial number (b)(6) was not returned for analysis, and no log files were provided.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 flow probe, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual provides information regarding emergencies/troubleshooting in section 9.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
B5: additional information.H10 - related report numbers.No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.
Event or Problem Description
The event did not happen while on a patient.The faulty censor was discovered as the customer was spinning a circuit to get ready to cannulate a new patient.After it was switched out it was sent to the sites bio-med engineer for evaluation who determined the censor was faulty.There was no record of what console the flow probe had come off of.Log files were not available.

• Brand Name: EM-TEC ADULT FLOW PROBE
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21127437
• Report Number: 3003306248-2025-00003
• Device Sequence Number: 6830282
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: (01)07640135140108(11)210916
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2025

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: Lay User/Patient
• Device Model Number: 201-30105
• Device Catalogue Number: 201-30105
• Device Lot Number: 8138973
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/18/2025; 03/07/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/05/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown