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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of an s3: system fault alarm was confirmed via the log file that was extracted from the centrimag console during testing.Data from (b)(6) 2024 was reviewed.The system was power cycled multiple times throughout the data, and the pump operated at intended set speeds.Three s3: system fault alarms were observed correlating to flow- and communication-related sub-faults.Due to the alarms, the flow value displayed as 0 lpm while the system was in use; however, the alarms did not prevent the system from operating at intended set speeds.The alarms intermittently cleared and reactivated upon each power cycle.No other notable events were observed.The returned centrimag flow probe (serial number 91704) was functionally tested at the european distribution center and at the product performance engineering department.Atypical events were unable to be reproduced throughout all testing, and the probe fully functioned as intended.Available information for this event indicates that the patient was switched to backup equipment with no symptoms to resolve the event.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for centrimag flow probe, serial number 91704, showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 3 "warnings and precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 11.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the console had an s3 alarm.It was noted that a patient was on the system for a brief time.The console was restarted but it still had the alarm active.The patient was moved to a backup system with new console, motor, and flow probe.The new products worked as expected and the patient had no symptoms related to the event.

• 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: 20043660
• Report Number: 3003306248-2024-04415
• Device Sequence Number: 7959404
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: (01)07640135140108(10)
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K020271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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: 201-30105
• Device Catalogue Number: 201-30105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• 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: 08/14/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2016
• 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 Sex: Unknown