MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION ADULT FLOW PROBE 1/4; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	104298
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involved in the event.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 product was defective out of the box.The flow probe was placed back in the box an labeled as defective.The flow probe did not include a manufacture label.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported events of an out of box issue and the centrimag flow probe missing its manufacturing label were not confirmed as the centrimag flow probe was not returned for analysis and no log files were submitted for review.Multiple attempts were made to obtain additional information (including if there was an out of box issue with the flow probe and if the manufacturer label was missing); however, no response was received.The root cause of the reported events 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 related alarms, and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST GENERATION ADULT FLOW PROBE 1/4
• 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: 11849438
• Report Number: 3003306248-2021-01107
• Device Sequence Number: 11699156
• Product Code: DWA
• UDI-Device Identifier: 07640135140146
• UDI-Public: 07640135140146
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: Health Professional
• Device Model Number: 104298
• Device Catalogue Number: 104298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1