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

Model Number 102956

Device Problems Infusion or Flow Problem (2964); Insufficient Information (3190)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported that the centrimag motor failed when it was not in use on a patient.The clinician reported that they were setting up an extracorporeal membrane oxygenation circuit and testing the device and got error s3, motor alarm m4, and the screen on the console would go blank.The clinician also reported a lot of beeping at the time of the event.Troubleshooting was performed by turning the console off and restarting it after the first error.Rotations per minute were unable to be increased and the machine constantly beeped.The machine was unable to be silenced, then an error message of "motor failure" came across followed by the console screen going black.The clinician then got a new console and plugged in the motor.When it was turned on, the same exact problem persisted.The clinician then got a new motor and plugged it in and tested it, and both consoles functioned as intended which allowed the clinician to confirm that the motor was the issue.

Manufacturer Narrative

Section a: no patient was involved.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: CENTRIMAG MOTOR, US
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18961974
• MDR Text Key: 338387688
• Report Number: 3003306248-2024-00455
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Lot Number: 7316527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• 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