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

Model Number	102954
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the patient had a low flow alarm while using centrimag, however the extracorporeal membrane oxygenation (ecmo) specialist noticed the flow was still at the set level.Then the revolutions per minute (rpm) and the flow dropped to zero.The console and motor were exchanged with the backup console and motor reportedly uneventfully although the patient's blood pressure did dip during the time off ecmo with no adverse patient impact.Related manufacturer reference number: 3003306248-2024-02752 (motor) related manufacturer reference number: 3003306248-2024-02753 (flow probe).
Additional Manufacturer Narrative
Section b1: corrected.Section d1: corrected.Section d4, primary udi number: corrected.Section h1: corrected.Section h5: corrected.Section h8: corrected.Manufacturer's investigation conclusion: the reported event of a flow alarm was unable to be confirmed.The centrimag console was not returned for analysis and no log files were submitted for review.A root cause for the reported event was unable to be conclusively determined through this investigation.The device history records were unable to be reviewed for the centrimag console due to no serial number being provided.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 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: 19513720
• Report Number: 3003306248-2024-02754
• Device Sequence Number: 11780119
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: (01)07640135140672
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 102954
• Device Catalogue Number: 102954
• Device Lot Number: 600279849
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown