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

Model Number 201-90411

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Insufficient Information (3190)

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

Event Date 09/11/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested but not yet provided.A supplemental report will be submitted once the manufacturer's investigation is completed.

Event Description

It was reported that during bivad centrimag support the centrimag mag monitor flow display stopped displaying values.Speed was displayed and blood flow remained to the patient.Blood flow was confirmed by attaching a separate non-cmag flow probe to the system.The cmag flow probe was exchanged which then displayed down arrows.The console and flow probes were removed and the patient was switched to a backup system without incident.Flow probe mfr#: 3003306248-2022-12519, motor mfr#: 2916596-2022-14112.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of blank flow and s3 alarms was confirmed.The centrimag 2nd generation primary console (serial#: (b)(6) was returned for analysis and a log file was downloaded for review with events spanning approximately 5 days (10sep2022 ¿ 13sep2022, 29sep2022 per time stamp).Events occurring on 29sep2022 took place during testing at abbott.The console was operating a motor at a speed of ~4800 rpm with a flow of ~6.5 lpm.On (b)(6) 2022 at 16:24, a ¿system alert: s3¿ activated following a ¿sf_flow_supply_5v¿ sub-fault.The flow dropped to 0 lpm; however, the speed remained the same.S3 alerts continually activated throughout the log file and flow remained blank.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was evaluated and tested at the service depot.The console was connected to a test loop, and it was observed that the console did not display flow, confirming the reported event.The console was further investigated, and it was determined that the flow printed circuit board (pcb) was not functioning as intended.The customer did not provide a purchase order for repairs despite several attempts.The console was returned to the customer unrepaired.The root cause for the reported event was conclusively determined to be due to an issue with the flow pcb; however, a further root cause was unable to be determined.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 qa specifications.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 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including s3 alarms.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was later reported that the system received s3 codes.After switching the patient to the backup system, the console and flow probe were connected to a mock loop and the s3 alarms were reproduced.

Manufacturer Narrative

Additional information to the manufacturer's investigation conclusion: the centrimag 2nd generation primary console was evaluated and tested at the service depot.The console was connected to a test loop, and it was observed that the console did not display flow, confirming the reported event.The console was further investigated, and it was determined that the flow printed circuit board (pcb) was not functioning as intended.Replacing the flow pcb resolved the issues.The console was functionally tested and returned to the customer.The flow pcb was returned to product performance engineering (ppe) for further analysis.The flow pcb returned to ppe in unremarkable condition.The pcb was connected to a test console.Upon powering up, a ¿system fault: s3¿ alarm was active.The motor speed was increased, but the flow remained blank ¿--.--".Further troubleshooting was unable to be performed due to the board being manufactured by a third party supplier.The root cause for the reported event was conclusively determined to be due to an issue with the flow pcb; however, a further root cause was unable to be determined.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: 15487155
• MDR Text Key: 306422325
• Report Number: 3003306248-2022-12512
• 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,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• 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
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2015
• 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
• Patient Sex: Male