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

Model Number 201-90411

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient was placed on circulatory mechanical support due to severe hypoxemia due to sarscov 2.The patient was in a very critical condition due to their pathology.Upon issuing the centrimag there was a m4 alarm and after 30-40 seconds the motor stopped.The patient was immediately switched to the backup motor.The patient did not present any complications from this event.Related manufacturer report number 3003306248-2021-04012.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag console was evaluated due to the reported event of an m4: motor alarm.However, the centrimag console was not returned for analysis, and no log files were associated with the reported event.The root cause of the reported event was determined to have been an issue with the returned centrimag motor (serial number (b)(6) ) and has been addressed via the motor¿s investigation.The serial number of the centrimag console was not provided.The 2nd generation centrimag system operating manual provides information regarding emergencies/troubleshooting in section 10.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: 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: 12290182
• MDR Text Key: 265576790
• Report Number: 3003306248-2021-04013
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1