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

Model Number 201-90411

Device Problem Unexpected Shutdown (4019)

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

Event Date 07/30/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022 there was a pump failure.It was reported that there was loss of rpm's and flow.It was suspected that there was a possibility that the motor chord came loose or that there was something wrong with the motor or console.Motor mfr report # 3003306248-2022-12495.

Manufacturer Narrative

Manufacture¿s investigation conclusion: the reported event of loss of pump speed and flow was able to be confirmed via review of the log file; however, was unable to be reproduced during product testing.The centrimag motor (serial number: (b)(6)) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 6 days ((b)(6) 2022 per timestamp).Events captured on (b)(6) 2022 took place in the testing labs at abbott.The console was operating a motor at a speed of ~4000 rpm and a flow of ~3.4 lpm.On (b)(6) 2022 at 04:17:00, a system alert: s3¿ alarm was activated and the pump speed fell to 3000 rpm causing a ¿pump speed not reached: m5¿ alarm to activate.The alarm was followed by a ¿motor alarm: m4¿ triggered by sub-fault ¿sf_lmc_levitation¿.The pump speed was changed multiple times on (b)(6) 2022 from 04:17:00 ¿ 04:24:00.The motor was disconnected and the system was shut down on (b)(6) 2022 at 04:24:00.The motor was connected and the system was shut down periodically from (b)(6) 2022 at 10:41:00 ¿ (b)(6) 2022 at 10:00:00.The pump speeds were intermittently adjusted throughout this duration as well.A can bus send error and system alert: s3 alarms were active on (b)(6) 2022 at 10:51:00.The system was shut down on (b)(6) 2022 at 10:00:00.There were no other notable alarms active in the log file.The centrimag motor (serial number: (b)(6)) was returned for analysis to the service depot.The console and motor was connected to the returned and associated motor and a mock loop for several days.During operation there were no alarms observed and it operated as intended.The reported event was unable to be reproduced.Multiple good faith effort attempts were made asking if the cause of the loss of flow/pump speed was identified, if the alarms were resolved, if any troubleshooting was performed, and if product will be returning; however, no response was received.The root cause of the reported event was unable to be conclusively determined through this investigation.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 13 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot system alarms including m4 and s3 alarms.The device history records were reviewed for the centrimag motor and the motor was found to pass all manufacturing and 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: 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: 15158902
• MDR Text Key: 304959970
• Report Number: 3003306248-2022-12494
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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