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

Model Number 201-30300

Device Problem Insufficient Information (3190)

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

Event Date 02/21/2023

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 the out of hospital rescue of a patient on extracorporeal membrane oxygenation (ecmo), the centrimag console presented an s3 alarm.There was no problem or interference with the patient care or support.Upon arrival at the institution, the console was exchanged without presenting any problem or consequences for the patient and the alarms resolved.Related manufacturer refence number: 3003306248-2023-01392.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console displaying a s3 alarm was confirmed via the submitted log file; however, it was not reproduced.A log file was downloaded from the returned centrimag console.A log file was downloaded from the returned centrimag console.A review of the downloaded log file showed events spanning approximately 6 days ((b)(6) 2023, (b)(6) 2023, (b)(6) 2023, (b)(6) 2023, (b)(6) 2023, and (b)(6) 2023 per time stamp).There were three power cycles prior to the system being powered on at 17:40:13 on (b)(6) 2023.Throughout the log file, there were several set speed changes.The console was operating a motor at a speed of between 0 rpm and 3050 rpm.On (b)(6) 2023 at 22:17:11 following turning the console on, the "system alert: s3" alarm activated due to a sf_lmc_motor_iic sub fault flag.The alarm was muted at 22:17:13.Pump speed remained at 0 rpm while the s3 alarm was active.The alarm did not affect the system from operating as intended.There were no other notable atypical alarms active in the log file.The returned centrimag console, serial (b)(6), was evaluated at the service depot.The reported issue could not be duplicated.The returned console was connected to a test loop and run for several days.During the investigation period no alarms or abnormal operation was observed.The returned console was opened and further inspected.The console passed all functional testing and was returned to the customer.Additional information provided stated that the console exchange resolved the alarms.A root cause for the reported event was unable to be conclusively determined.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console was found to pass all manufacturing and quality assurance specifications.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.The 2nd generation centrimag system operating manual (rev.M) provides information regarding emergencies/troubleshooting in section 9.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 (rev.M) section 11.1 entitled "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.The 2nd generation centrimag system operating manual (rev.M) section 9 "maintenance" states that the battery maintenance procedure needs to be performed every 6 months.If the system requires the battery maintenance procedure to be performed, it will display the alert.Additionally, it mentions to replace the internal rechargeable battery every 2 years.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16632323
• MDR Text Key: 312224029
• Report Number: 3003306248-2023-01391
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

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: 201-30300
• Device Lot Number: L07398
• 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: 03/23/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2020
• 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