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 03/16/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a motor failure on the centrimag system.Related manufacturer's report: 2916596-2023-01707.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an issue with the motor was not confirmed.The centrimag 2nd generation primary console was returned for analysis and a log file was downloaded for review with events spanning approximately 12 days (11jan2023 ¿ 12jan2023, 14jan2023, 16jan2023, 18jan2023, 30jan2023, 01feb2023, 05feb2023, 06mar2023 ¿ 07mar2023, 10mar2023, 21mar2023 per time stamp).Events occurring on 21mar2023 took place during testing at abbott.There were no notable events active in the log file.The reported event could not be confirmed via the log file analysis.The centrimag 2nd generation primary console was returned for analysis to the service depot and the reported event was unable to be reproduced during testing.The console was connected with the returned and associated centrimag motor and a mock loop and was run for several days with no alarms.The console was opened for internal inspection and no anomalies were observed.The console was run independently for several days with no issues.Multiple good faith efforts were sent to retrieve additional information regarding if there was patient involvement in the reported event, if there were any adverse patient impacts, events leading up to the reported motor issue, and if there were any alarms during the event; however, no response was received.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag 2nd generation primary console and the console was found to pass all manufacturing and qa specifications.The battery was originally shipped with the console.The 2nd generation centrimag system operating manual (rev.M) 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." the 2nd generation centrimag system operating manual table 15 entitled "console maintenance schedule" states to replace the internal battery every two years.No further information was provided.The manufacturer is closing the file on the 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16675583
• MDR Text Key: 313563916
• Report Number: 2916596-2023-01708
• Device Sequence Number: 1
• Product Code: DWA
• 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: 04/20/2023

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: L06340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• 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