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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the flow probe was not working with the centrimag console.It was noted that a prong in the flow probe was bent/missing.This resulted in the flow probe being unusable.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a bent pin in the centrimag flow probe connector confirmed via evaluation of the returned flow probe (serial number: (b)(6)).Visual inspection of the returned flow probe revealed that one of the pins in the connector was bent.The returned flow probe was connected to a known working test centrimag system; however, the flow probe connector could not be fully seated to the connector on the centrimag console due to the bent pin.A flow signal interrupted: f2 alarm also activated due to the flow probe not being able to fully connect to the console.The bent pin was then straightened to continue with testing.After straightening the bent pin, the flow probe connected to the console without any issues and no atypical alarms were produced.The root cause of the reported event could not be conclusively determined through this analysis.The 2nd generation centrimag system operating manual (rev.11) section 10 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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.The 2nd generation centrimag system operating manual (rev.11) section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including flow alerts, and the appropriate actions to take if the issue does not resolve.The device history records were reviewed and the records revealed that the centrimag flow probe, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this 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
• MDR Report Key: 12222668
• Report Number: 3003306248-2021-02994
• Device Sequence Number: 17134320
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: 07640135140108
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 07/24/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1