MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	201-90411
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while priming the circuit, the console went from 1500 to 0 rotations per minute (rpm).The console randomly stopped flowing and a low flow alarm occurred.It was unplugged and turned back on.Related manufacturer reference number: 3003306248-2023-07173 (centrimag motor model #: 102956).
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of low flow and speed alarms was confirmed via log file analysis.The centrimag 2nd generation primary console (serial number: (b)(6)) was returned for analysis and a log file was downloaded for review that showed events spanning approximately 7 days ((b)(6) 2023, (b)(6) 2023, (b)(6) 2023, (b)(6) 2023 per time stamp).Events occurring on (b)(6) 2023 took place during lab testing at abbott.On (b)(6) 2023 intermittent ¿flow below minimum: f3¿ and ¿set pump speed not reached: m5¿ alarms were active.The flow and motor speed dropped to 0 lpm and 0 rpm respectively.Flow and motor speed resumed shortly after each alarm.The pump was stopped due to a user request on (b)(6) 2023 at 16:27 and a system shutdown was performed shortly after the pump stop at 16:33.The console was power cycled several times before the system was shutdown to be forwarded to abbott.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis to the service depot where it was functionally tested and operated as intended.The reported event was unable to be reproduced during testing and was sent back to the customer ready for use.Multiple good faith efforts were sent regarding resolution of the reported event, if any troubleshooting was performed, if a patient was involved, and if any more alarms had occurred.To date, no response had been provided.The root cause for the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed for the centrimag 2nd generation primary console and the console was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 entitled "warnings & 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 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual table 16 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including f3 and m5 alarms.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND 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: 17940474
• Report Number: 3003306248-2023-07172
• Device Sequence Number: 20422798
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: 07640135140672
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131179
• 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): 01/11/2024

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: 201-90411
• Device Lot Number: 6573871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2017
• 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