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 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a centrimag motor kept alarming s3 alert.This alarm occurred in the priming and start up period when they switched out the motor from one centrimag console to another.Related manufacturer's report number for the centrimag motor: 3003306248-2023-08407.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of an s3 alarm was confirmed.The centrimag 2nd generation primary console (serial number: (b)(6)) was returned for analysis and a log file was downloaded for review that showed events spanning approximately 6 days (03dec2023 ¿ 06dec2023, 08dec2023, 11dec2023, 04jan2024 per time stamp).Events occurring on 04jan2024 took place during lab testing at abbott.The log file captured intermittent atypical s3 alarms active from 05dec2023 at 16:13:54 - 06dec2023 at 19:49:54 due to a sf_sps_fan_speed sub fault flag.The alarm was muted and cleared several times throughout this duration.There were no other notable atypical alarms active in the log file.The centrimag 2nd generation primary console and returned centrimag motor (serial number: (b)(6)) were connected to a test loop and run for several days without any issues or alarms activating.The console was opened, and a buildup of dust was observed around the fan assembly.The console was thoroughly cleaned internally and was functionally tested.The console passed all tested and was returned to the customer.Additional information received on 15dec2023 stated none of these events happened while on a patient.They all occurred in the priming and start up period.The root cause of the reported event could not be conclusively determined through this analysis; however, a damaged fan assembly and excess dust being inside the unit could have contributed to the reported event.The device history records were reviewed for the centrimag 2nd generation primary console (serial number: (b)(6)) and the console was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 entitled "warnings & 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 section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." reviewed and found complete.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18382865
• MDR Text Key: 331201449
• Report Number: 3003306248-2023-08408
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• 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,Followup
• Report Date: 03/12/2024

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 Expiration Date: 08/31/2021
• Device Model Number: 201-90411
• Device Lot Number: 7151859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2019
• 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