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 Failure to Charge (1085)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

It was reported that the centrimag console could not connect to main power.The internal battery would not charge when connected to socket power.The console only used battery power.The power cable was exchanged to troubleshoot but the issue could not be resolved.

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.E: reporter email and address were not available.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console being unable to start was able to be confirmed.The centrimag 2nd gen.Primary console (serial number: (b)(6)) was returned for analysis, and log files were downloaded for review.A review of the submitted log files showed events spanning approximately 4 days (01jan1970, 01jan2000, 13dec2023, 01mar2024, 03mar2024 per timestamp).Events captured on 01jan1970 occurred due to a time variable overflow resulting in the clock to reset to a default date.Events captured on 01jan2000 took place when the clock was not set.Events captured on 13dec2023, 01mar2024 and 03mar2024 took place at abbott.Multiple startup sequences were observed and was found to be unable to pass the initial startup self-test.The console showed that it was powered on by battery power and multiple shutdown sequences were noted resulting in the console to restart and rerun the self-test.In the event that the console was able to successfully startup, sf_ifd_intercom_can_b_tx/rx sub-faults were intermittently active; however, no alarms were observed due to the faults.No alarms activated during this period.There were no other notable alarms active in the log file.The centrimag 2nd gen.Primary console was returned and was evaluated.The console was connected to a power and the system shutdown sequence flashed on the display.The console was unable to be powered on.During evaluation at the european distribution center, the console was able to be powered on after doing the following steps: applying ac power with the battery disconnected, then inserting the battery during the watchdog error, and then applying ac power afterwards to resolve the watchdog and main errors.Following this sequence, the console was able to operate under normal condition.During further evaluation of the console with the product performance engineering group, the console was connected to power and the shutdown sequence would intermittently activate and shutdown the console.The console would alarm at random and was unable to be shut down using the prompts on the screen.The console was opened and underwent circuit analysis.The power supply from the ac power cord and battery power were measured and no issues were observed.The console was connected to power and operated for an extended duration where alarms would activate and resolve on their own.The console functioned as intended when the alarms cleared but the alarms intermittently reactivated throughout testing.The returned console is a version 1 2nd generation primary console and various part of the console are obsolete and unavailable.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records for the centrimag 2nd generation (2nd gen.) primary console (serial number: (b)(6)) were reviewed and was found to pass all manufacturing and qa specifications before being shipped to the customer.The 2nd generation centrimag system operating manual 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." 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18325159
• MDR Text Key: 330954535
• Report Number: 3003306248-2023-08402
• 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: 03/29/2024

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: 201-90401
• Device Lot Number: 5740591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2011
• 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