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	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the centrimag system stopped running while connected to the patient.The staff replaced the console and motor, and the patient was not harmed.
Additional Manufacturer Narrative
A1-a4: patient information not provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
D4: product sn and udi corrected.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was additionally reported that the patient returned from the catheterization laboratory and the centrimag console and centrimag motor stopped functioning.There was zero flow on the centrimag screen, and upon palpitation of the motor there was no vibration.The centrimag had to be emergently swapped out to a backup centrimag to get the patient's extracorporeal membrane oxygenation (ecmo) circuit running.It was confirmed that exchanging the console and motor resolved the issue.It was noted that the equipment service report sent to the customer from abbott noted the issue as being with the motor and the cord being flexed causing the m4 error.The motor was deemed unable to be repaired and was replaced.
Additional Manufacturer Narrative
Section d4: corrected.Manufacturer's investigation conclusion: the reported event of the centrimag system stopping unexpectedly was confirmed via the centrimag motor¿s investigation (see manufacturer report number 2916596-2024-06297), and it was determined that the console was unrelated to the cause of the event.The returned centrimag console (serial number (b)(6) was functionally tested at the service depot and performed as intended throughout all testing.The console was returned to the customer site after passing all tests per procedure.The root cause of the reported event was isolated to an issue with the centrimag motor and was not correlated to an issue with the console.Review of the device history record for centrimag console, serial number l07166-0001, showed the device was manufactured in accordance with 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 / 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." 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20330512
• Report Number: 3003306248-2024-06296
• Device Sequence Number: 13162503
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: (01)07640135140672
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2024

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 Catalogue Number: 201-90411
• Device Lot Number: 7569858
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 12/11/2024
• Initial Report FDA Received Date: 09/29/2024
• Supplement Report FDA Received Date: 12/06/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2020
• 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