MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	102954
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related mfr: 3003306248-2023-05032, related mfr: 3003306248-2023-05031, related mfr: 3003306248-2023-05034.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the patient was on centrimag support.On (b)(6)2023, the centrimag alarmed while a nurse was in the room.The nurse noted dashes on the flow probe reading, at that time they heard a ¿swishing sound, or a water through hose¿ sound coming from the pump, at the same time the patient became suddenly agitated, as if the response was to something painful.The event lasted 15 seconds, and the flow reading returned to baseline without intervention on the flow probe.No changes in patient assessment or monitor vitals were noted.Log files were obtained, and the entire system was changed on (b)(6)2023.There were no alarms reported during this event.It was later communicated that the patient was stable and waiting for a heart transplant.The cause of the swishing sound was not determined.The sound reportedly resolved prior to the equipment being exchanged and only lasted about 15 seconds.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a blank flow reading was confirmed via analysis of the submitted log file.On the reported event date of 17jul2023, the system was observed to be operating the motor at a speed of approximately 3400 revolutions per minute (rpm) with a flow of approximately 1.8 liters per minute (lpm).On (b)(6) 2023 at 06:36 and at 14:45, f2: flow signal interrupted alarms activated, causing the patient¿s flow value to read as 0 lpm.These alarms were muted and cleared within a minute of activating and correlated to fault flags that may indicate a potential communication issue.The alarms did not affect the system¿s ability to operate the motor at the set speed.The centrimag console was not returned for analysis.Additional information provided communicated that product would be returned to abbott for analysis; however, to date no products have been returned to abbott.This file will be reopened with further analysis if any products are returned at a later date.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the centrimag console was manufactured in accordance with manufacturing and qa specifications.The centrimag console was shipped to the customer on (b)(6) 2015.The 2nd generation centrimag system operating manual 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 section 12.1 ¿ "appendix i ¿ 2nd generation centrimag 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 PRIMARY CONSOLE
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17473890
• Report Number: 3003306248-2023-05033
• Device Sequence Number: 20678197
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: 07640135140672
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K093832
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 102954
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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 Age: 5 MO
• Patient Sex: Male
• Patient Weight: 7 KG