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

Model Number 201-30300

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/03/2023

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 when it was attempted to purge the pump, the flow probe was not detected.The flow probe was exchanged, but it still would not measure the flow.The centrimag console was exchanged, and the patient was admitted with the new console.The patient was in good general condition and there was no adverse patient impact.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console not detecting the flow probe was able to be confirmed via review of the log file; however, it could not 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.The downloaded log files contained events spanning approximately ~20 hours of use (18:08 on (b)(6) 2022 to 11:01 on (b)(6) 2022, 23:05 on (b)(6) 2022 to 1:45 on (b)(6) 2022, and 15:03 to 15:04 on (b)(6) 2022).Occasionally throughout the data, atypical ¿flow signal interrupted¿ alarms were observed.While these alarms were active, the flow value read as 0 rpm, despite the pump running at its set speed.There were also a few ¿flow sensor disconnected¿ alarms seen on (b)(6) 2022; these alarms may have been related to the reported replacement of the flow probe.The returned console was functionally tested and found to perform as intended.The reported event could not be reproduced, and the root cause of the issue was unable to be determined through this evaluation.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 those associated with motor stop and flow signal interruption conditions.The device history records were reviewed for the centrimag 2nd generation console (serial #: (b)(6)) and the console 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: 16216655
• MDR Text Key: 309049116
• Report Number: 3003306248-2023-00003
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Device Lot Number: L06365
• 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: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2018
• 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