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

Model Number 201-30300

Device Problem Insufficient Information (3190)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.Section e1: reporter address line 1: (b)(6) section e1: reporter postal office or zip code: (b)(6).

Event Description

It was reported that during patient support the centrimag console issued an s3 alarm.The fan was checked for blockages or for overheating.The console was cleaned.Approximately 15 minutes later, the alert disappeared and the computer continued to function normally.There were no patient consequences.Motor mfr # 3003306248-2024-00425.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console displaying a s3 alarm was not confirmed.There were no photos or log files submitted for review.The centrimag console, serial (b)(6), was not returned for analysis.The provided information indicated that the patient experienced an s3 alarm.The console was checked for blockages and overheating.By leaving the console uncovered of objects with no obstruction for 15 minutes, the alert disappeared, and unit continued to function normally.There were no consequences for the patient.Additional information provided stated that log files were not downloaded and the cause for the alarm was not determined but both the motor and the console continued to function fine.The 2nd generation centrimag system operating manual section 9.2 states to clean the exterior of the console with bactericidal solution by spraying the solution on a cloth and wiping off the unit after disconnecting from ac power.A root cause for the reported event was unable to be conclusively determined.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6) and the console was found to pass all manufacturing and qa specifications.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.The 2nd generation centrimag system operating manual (rev.M) provides information regarding emergencies/troubleshooting in section 9.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.The 2nd generation centrimag system operating manual (rev.M) section 11.1 entitled "appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including s3 alarms, as well as appropriate operator response to these events.The 2nd generation centrimag system operating manual (rev.M) section 9 "maintenance" states that the battery maintenance procedure needs to be performed every 6 months.If the system requires the battery maintenance procedure to be performed, it will display the alert.Additionally, it mentions to replace the internal rechargeable battery every 2 years.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 CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18735492
• MDR Text Key: 336759172
• Report Number: 2916596-2024-00803
• Device Sequence Number: 1
• Product Code: DWA
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Lot Number: 8885313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2011
• 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
• Patient Sex: Male