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

Model Number 201-30300

Device Problem Noise, Audible (3273)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, during centrimag equipment setup, rattling like a loose screw was heard.This occurred when the centrimag 2nd generation primary console was removed from the box.The box and foam packaging were intact and appeared as expected.No damage was visualized to the outside of the console.

Event Description

The console was taken out of service and a replacement request was made.There were no alarms noted.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of a loose component within the centrimag console, causing a rattling noise to occur, was confirmed.The returned centrimag console (serial number (b)(6)) was received at the service depot, where a loose metal nut was confirmed to be within the console¿s housing upon opening the unit.No missing hardware was observed within the console, and all components were observed to be properly secured, indicating that the loose metal nut was an extra component.The nut was removed, then the console was functionally tested and was found to perform as intended.As the customer had already received a warranty replacement console, the serviced and tested console was removed from service after passing all tests per procedure.A manufacturing analysis task was created under this event to address the issue of a loose nut within the console.The task determined that the most likely root cause of the event was a handling error of the operator and an incorrect execution of the final test.Awareness training was conducted on (b)(6) 2024 to all operators performing the centrimag console assembly, clearly showing the picking process of the required materials and the correct execution of the final test.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 section 4 "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." 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: 18933881
• MDR Text Key: 338449211
• Report Number: 2916596-2024-01370
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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 Model Number: 201-30300
• Device Lot Number: 10065874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2023
• 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