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

Model Number 201-90411

Device Problem Failure to Power Up (1476)

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

Event Date 01/15/2024

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 the centrimag 2nd generation primary console would not power on; the fuses kept blowing even after being replaced.

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the reported event of the console not powering on and the fuses being open was confirmed via evaluation.A log file was extracted from centrimag console (b)(6).A review of the log file contained data spanning (b)(6) 2022 ¿ (b)(6) 2024, per timestamps.The console was not put in patient use throughout the reported event month of january 2024; however, the console was observed to be powered on several times.The system powered off after approximately 30 ¿ 90 seconds each power on attempt.Additionally, the console was operating on battery power, indicated by ¿on battery: b6¿ alarms.The console was not attempted to be powered on again before being forwarded to the service depot.On (b)(6) 2024 at 12:03:51, during analysis at the service depot, an s1 alarm activated due to a power on self-test not passing.The console shutdown approximately ~50 seconds later.The centrimag 2nd generation primary console (s/n: (b)(6)) was inspected at the service depot.Inspection of the centrimag console revealed that both fuses in the power entry module did not have continuity.The fuses were replaced, and the unit was connected to alternating current (ac) power.Upon powering on the console, both fuses opened.The console was disassembled, and the issue was isolated to the 24v power supply printed circuit board (pcb).The power supply pcb was replaced, and the console was able to operate as intended.The console was functionally tested and passed without issue.The unit was returned to the customer site and the damaged power supply pcb was forwarded to product performance engineering (ppe).Upon further analysis with ppe, no physical anomalies were observed.The 24v power supply is manufactured by a 3rd party and the device schematics are unavailable for troubleshooting.No further testing could be performed.The root cause of the reported event was determined to be due to the 24v power supply; however, a further root cause was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag console and the console was found to pass all manufacturing and qa specifications.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 4 ¿ "warnings & precautions" states that 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 pedimag 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 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including s1 and battery alarms, and the appropriate actions to take if the issue does.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: 18606167
• MDR Text Key: 334095812
• Report Number: 3003306248-2024-00020
• 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: 05/13/2024

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: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• 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