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

Model Number 201-90411

Device Problem Data Problem (3196)

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

Event Date 08/03/2022

Event Type  malfunction  

Event Description

It was reported that the patient has been on centrimag support for 24 hours.The nursing specialists have been charting p1>p2 negative delta p and did not realize that until the morning of (b)(6) 2022.The perfusionist leveled the transducers, flushed them, re-zeroed them and re-calibrated p1 and p2, changed pressure cables, and changed out transducers all without resolution.All connections from patient through the circuit were correct and secure, and the pressure cables were connected correctly in the back of the centrimag console.The center turned on the backup centrimag console and plugged in the pressure cables, which showed the correct data of p2>p1 with a positive delta p.For the time being, the center has decided to switch the pressure cables in the back of the primary console and continue to run the patient until they are no longer on support.Once off the centrimag, the center will send the console to biomed and abbott for servicing.On (b)(6) 2022 it was communicated that the patient was off of the centrimag, and it was shipped out for analysis.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the pressure difference between p2 and p1 being a negative value was confirmed via evaluation of the returned centrimag console.The returned centrimag console (serial number: (b)(6)) was evaluated by service depot alongside known working test centrimag equipment.During testing, it was observed that the visual display for the pressure readings, p1 and p2, were being displayed in the reversed positions on both the console¿s display and on the monitor¿s display.The returned console was then disassembled to inspect the internal components, revealing that the p1 pressure cable connector was connected to the p2 socket on the printed circuit board (pcb) and the p2 pressure cable connector was connected to the p1 socket on the pcb.The p1 and p2 pressure cables were reconnected to the correct sockets on the pcb, and after reconnecting the cables the pressure readings displayed in the correct positions on both the monitor¿s display and on the test monitor, resolving the issue.The console was then functionally tested, and the unit fully functioned as intended during testing.The serviced and repaired unit was returned to the customer site after passing all tests per procedure.A log file was downloaded from the returned centrimag console.The system was observed to be operating the pump at the set speed without any issues.The system was observed to be manually shut down on 05aug2022 at 23:33 and was not observed to be in patient use for the remainder of the log file.No notable alarms were observed in the log file.The reported event was determined to be caused by the pressure cable connectors being connected to the opposite sockets on the pcb.A manufacturing analysis task was opened to further investigate this issue.Per the manufacturing analysis task, the assembly procedure and final test procedure will be updated to further control the process of manufacturing the centrimag console.A mark will be added to the pressure cable socket on the pcb and connector on the p1 pressure cable to prevent future mix ups.Additionally, operators will be trained to the updated procedures to ensure correct execution of the updated procedures.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 quality assurance specifications.The console was shipped to the customer on 23aug2021.The 2nd generation centrimag system operating manual section 10 ¿ ¿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.The 2nd generation centrimag system operating manual section 12.1 ¿ "appendix i ¿ 2nd generation centrimag primary console alarms and alerts" cover all alarms (auditory and visual), and the appropriate actions to take if the issue does not resolve.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 CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15270034
• MDR Text Key: 305346362
• Report Number: 2916596-2022-12796
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7985988
• 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: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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
• Patient Age: 13 DA
• Patient Sex: Male
• Patient Weight: 5 KG