MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; VENTRICULAR (ASSIST) BYPASS

Model Number 201-90411

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Event Description

Related mfr #2916596-2023-07088.It was reported that the centrimag motor stopped pumping and flow dropped to zero.

Manufacturer Narrative

A1-a4: patient information not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Correction: the initial report was incorrectly submitted with a cfn-based manufacturer report (mfr) number: 2916596-2023-xxxxx.The mfr number should have been fei-based with the 10-digit fei being 3003306248.Correction to d6b - this field was inadvertently filled in for the initial report; the device is not implanted.Manufacturer's investigation conclusion: the reported event of the pump stopping and the flow going to zero was confirmed via log file analysis.A review of the log file, extracted from the centrimag console, contained data spanning approximately 3 days ((b)(6) 2023 per timestamp).The pump was operating at a speed of ~2800 rpm with a flow of ~3.6 lpm.On (b)(6) 2023 starting at 19:53, a ¿flow below minimum: f3¿ alarm activated due to the flow falling to ~0.5 lpm.The alarm was cleared at 19:54 and the flow resolved on its own.On (b)(6) 2023 at 0:04, a ¿flow signal interrupted: f2¿ alarm activated, causing the patient¿s flow value to read as 0 lpm.The flow issue did not resolve in the log file.At 0:08, a ¿sf_lmc_shutdown_initiated¿ event activated and a ¿pump not inserted: m3¿ alarm was active.The pump speed fell to 0 rpm.The m3 alarm was muted and cleared at 0:09 and the pump regained speed around ~2300 rpm.At 0:11 the pump was stopped due to user request and at 0:14 the system was shut down.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console (s/n: (b)(6)) was evaluated at the service depot.The console underwent functional testing and operated as intended.The console was connected to the returned motor and flow probe was able to operate on a test loop for several days with no alarms, even when the motor cable was flexed throughout its entire length.The console was returned to the customer ready for use.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause for the reported event was unable to be conclusively determined through this analysis.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." the 2nd generation centrimag system operating manual, table 16 entitled ¿console alarms & alerts¿ addresses how to interpret and troubleshoot all system alarms including motor and flow alarms.The device history records were reviewed for the centrimag console (s/n: (b)(6)) and the console was found to pass all manufacturing and quality assurance (qa) specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17889150
• MDR Text Key: 325852513
• Report Number: 2916596-2023-07087
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2013
• 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