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	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was reported as having no patient involvement.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
Related mfr #s: 3003306248-2021-01076, 3003306248-2021-01078.It was reported that the centrimag console displayed error messages b4 and f3.Flow could not be increased with an increase in the rpm.The customer switched out the console, motor, and flow probe for their backups.
Additional Manufacturer Narrative
Main investigation conclusion: the centrimag flow probe (serial number: (b)(6) ) was returned for evaluation following the reported event of f3 and b4 alarms on the centrimag console, and the flow not increasing when the motor speed was increased.However, it was determined that the returned flow probe was unrelated to the cause of the event.The returned centrimag flow probe was functionally tested by service depot and the unit operated as intended throughout all testing.The serviced and tested unit was returned to the rental pool after passing all tests per procedure.It was revealed that the root cause of the reported event was related to the returned centrimag console (serial number: (b)(6) ).The console¿s evaluation along with the log file associated with this event have been addressed via the console investigation.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 battery and flow related alarms, and the appropriate actions to take if the issue does not resolve.The centrimag flow probe assembly is manufactured by the vendor who maintains the device history records no further information was provided.The manufacturer is closing the file on this event.

• 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
• MDR Report Key: 11598885
• Report Number: 3003306248-2021-01077
• Device Sequence Number: 3511649
• Product Code: DWA
• UDI-Device Identifier: 07640135140139
• UDI-Public: 07640135140139
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 07/23/2021

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: 102957
• Device Catalogue Number: 102957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CENTRIMAG MOTOR