MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE (WITH EMTEC PEDIATRIC FLOW PROBE) (VAS/; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90701

Device Problem Data Problem (3196)

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

Event Date 12/09/2022

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 there was an issue with the centrimag console on 09dec2022 regarding intermittent recording of the flow probe.The issue was believed to originate from the console as no different flow probe solved the problem.The flow probes worked on another console.The console was removed from use.

Event Description

The console was not being used on a patient at time of event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of issues with intermittent recording of the flow probe was able to be confirmed via review of the log file; however, was unable to be reproduced during product testing.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 4 days ((b)(6) 2022, (b)(6) 2023 per timestamp).Although there were no events found in the log file occurring on (b)(6) 2022, the log file recorded atypical flow related alarms on other dates.Flow sensor disconnected, flow signal interrupted, and low flow alarms were intermittently recorded on (b)(6) 2022 at 10:46 - 18:26.The alarms cleared immediately after activating.There were no other notable alarms active in the log file.Pump operation was not affected.The centrimag 2nd generation primary console was returned for analysis and was evaluated.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 root cause of the reported event was unable to be conclusively determined through this investigation.The device history records for the centrimag 2nd generation primary console (serial number: (b)(6)) were reviewed and was found to pass all manufacturing and quality assurance 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." the 2nd generation centrimag system operating manual table 16 entitled ¿console alarms & alerts¿ addresses how to interpret and troubleshoot all system alarms including f1, f2, and f3 alarms.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE (WITH EMTEC PEDIATRIC FLOW PROBE) (VAS/
• 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: 15971102
• MDR Text Key: 308442679
• Report Number: 3003306248-2022-14526
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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: 201-90701
• Device Lot Number: 7293986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2019
• 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