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

Model Number 201-30300

Device Problem Alarm Not Visible (1022)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/20/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient's centrimag device malfunctioned.The patient flows dropped to zero after a slight cough, but the rounds remained unchanged.The possibility of user error was high, as it was possible that no flow lower limit was set.The issue did not affect the patient who is stable.The console did not alarm.The patient's oxygen saturation dropped by about 10%.The patient was switched to backup device which returned saturation.The flow reading was displayed as a dash even though motor was running.Related manufacturer report number #: 3003306248-2021-01099.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console screen showing a blank flow was not confirmed as the centrimag console (serial number: (b)(6)) was not returned for analysis, and no log files were submitted for review.Additional information stated that no products would be returned for evaluation.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the centrimag console, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section- ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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
• MDR Report Key: 11642292
• MDR Text Key: 244909616
• Report Number: 3003306248-2021-01098
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

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: 201-30300
• Device Lot Number: L06066
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR (S/N#: (B)(4))