MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/22/2023

Event Type  malfunction  

Event Description

It was reported that the centrimag console had a battery alarm, but the alarm was not able to be acknowledged.The console needed to be disconnected from all power in order to be switched off.The battery power was not working.Regulatory reference report mfr # 3003306248-2023-01387.

Manufacturer Narrative

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

Event Description

Additional information: it was reported that the console was supporting a patient when battery issues occurred but no patient consequences.The patient was continued on support on another console.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental finding: damaged housing the reported event of an atypical battery alarm correlating to issues with ac power was confirmed.A log file was extracted from the returned centrimag console (serial number (b)(6)) and was reviewed.The system was observed to be operating around the set parameters throughout data recorded on 20 mar 2023 ¿ 21 mar 2023 per timestamp.On 21 mar 2023, an s3: system fault alarm correlating to the console¿s smart power supply (sps) was observed.Within the same minute, a few b6: on battery alarms were observed, also correlating to the console¿s sps.The s3 alarm was able to be cleared within the same minute of activation, and the battery alarms reactivated a few times upon being cleared throughout the next ~40 minutes.The system was observed to have been shut down on 21 mar 2023.Data from the reported event date, 22 mar 2023, was not observed within the data.No other notable events were observed.The returned centrimag console was received at the european distribution center.During the initial plug-in of the console to ac power, a watchdog beep sound was heard once.The device was approved to be scrapped and was forwarded to the product performance engineering (ppe) department for further analysis.Upon arrival at the ppe department, the console was connected to a mock loop and known working test equipment.Upon connecting the ac power cord to the console, a few audible tones were heard from the sps printed circuit board (pcb).The console was initially unable to properly power on with ac power, as the unit continuously attempted to shut down and reboot upon this initial connection.Then, the console was powered on without the ac power cord, operating on battery power.After the console passed its power-on self-test, the ac power cord was connected to the console, and the console was functionally tested.After this point in testing, the console fully functioned as intended.The console was powered off and on multiple times with the ac power cord connected and was also connected to an international power supply at 230v with 50 hz, and further atypical events were unable to be reproduced.The console was able to operate a mock loop on ac and battery power as intended throughout all testing.Although the reported event was confirmed via the log file and was partially reproduced and narrowed down to the sps pcb, further root cause was unable to be determined due to the issue becoming intermittent/resolving during testing.The root cause of the reported event was unable to be conclusively determined through this analysis.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 (rev.L) section 3 "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." the 2nd generation centrimag system operating manual (rev.L) section 11.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including s3 alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16612475
• MDR Text Key: 312245064
• Report Number: 3003306248-2023-01386
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

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: 201-90401
• 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: 03/22/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2011
• 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