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

Model Number L201-90401

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

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

Event Date 09/20/2022

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 the centrimag 2nd generation primary console was defective.

Event Description

Additional information reported that the console had showed an s3 alarm.

Manufacturer Narrative

Correction: the initial report was incorrectly submitted with a cfn-based manufacturer report (mfr) number: 2916596-2022-14109.The mfr number should have been fei-based with the 10-digit fei being (b)(4).Manufacturer's investigation conclusion: the reported event of a system fault alarm was unable to be confirmed.The centrimag 2nd generation primary console (serial number: (b)(6)) was returned for analysis and a log file was downloaded for review.A review of the downloaded log files showed events spanning approximately 6 days ((b)(6) 2022 ¿ (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2023 per timestamp).Events captured on (b)(6) 2023 took place in the testing labs at abbott.The event of system fault alarms was unable to be confirmed in the log file as the date of the reported event was overwritten and was not available.There were no other notable alarms active in the log file pertaining to the reported event.During the investigation there was an incidental finding of low flow alert on (b)(6) 2022 at 09:43 ¿ 09:48.The alarms were able to be muted and cleared once the pump was disconnected and the system was shut down on (b)(6) 2022 at 09:48.There were no other notable alarms active in the log file.The returned console was connected to a test loop and run for several days with no alarms observed.The returned console was externally and internally inspected, functionally tested and passed all tests and all components were found to be in good condition.The console was able to function as intended.The battery was soon to be expired and was replaced.No further testing was conducted.The root cause of the reported event was unable to be conclusively determined through this investigation.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 2nd generation centrimag system operating manual 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¿ details the various alarms and alerts and the appropriate operator response, including s3, and f3 alarms.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, OUS
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY 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: 15536682
• MDR Text Key: 301123787
• Report Number: 2916596-2022-14109
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L201-90401
• Device Lot Number: 5467990
• 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: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2012
• 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