MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problem Insufficient Information (3190)

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

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

All available information for conducting this investigation was collected and no additional follow-up attempts will be performed.

Event Description

It was reported that during preparation of the centrimag system, when the console was switched on all internal tests ran without issues and the console was in ready mode.When the pump was inserted for the deairing phase of circuit preparation, the pump did not start and a m4 was initiated.The primary console was restarted, but the alarm continued.The unit was removed and the backup was used.Motor mfr # 3003306248-2023-01944.Flow probe mfr # 3003306248-2023-01945.

Manufacturer Narrative

Manufacturer's investigation conclusion: the returned centrimag console, serial number (b)(6), was evaluated due to the reported event of the centrimag system not starting properly with an active m4: motor alarm.The unit was tested at the european distribution center (edc) along with the other returned centrimag equipment (motor (b)(6), and flow probe 120855), where the cause of the event was determined to have been related to an issue with the motor; this will be addressed in the motor investigation.The returned centrimag console was functionally tested at the edc and was found to perform as intended.A log file was extracted from the console and did not show any atypical events indicating an issue with the console.The serviced and tested console was returned to the customer site after passing all tests per procedure.Review of the device history record for centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.L) section 3 "warnings and 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 (rev.L, ¿table 15: console maintenance schedule¿) instructs users to have the centrimag console¿s internal battery replaced every two years.Users are instructed to contact abbott for assistance in replacing the battery, as users may not replace the internal battery without proper training or assistance.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information was received that the issue resolved after exchanging the centrimag system.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: 17075050
• MDR Text Key: 317588839
• Report Number: 3003306248-2023-01943
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-90401
• Device Lot Number: 7028394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1