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

Model Number 201-90411

Device Problems Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2019

Event Type  Injury  

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 on (b)(6) 2019 that around 2230 after 20 hours on ecmo the centrimag console alarmed that ¿set pump speed not reached¿ with the flow showing dashes ¿-¿.The rpms set at 4800 dropped to 3600.The flow probe was moved to a different part of the tubing but didn¿t change any parameters even after lowering manually the rpms, the backup console was booted up and clamped out the outlet of the pump head and was transferred to the backup motor head.The flow was re-established but noticed the original motor was very warm to the touch.A backup cart from the operating room was brought up and tested separately the flow probe and the motor head on the primed circuit worked as intended.Epats event form was started.No further information was provided.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the report of set pump speed not reached alarm, speed drop, and the flow reading showing dashes was confirmed through the analysis of a data log file retrieved from the returned 2nd gen primary console (serial number (b)(4)).The console was connected to a test mag monitor and a data log file was retrieved successfully.The retrieved data log file captured the console supporting a system for over 711 hours at a speed of approximately 4600rpm and a flow of approximately 4.5lpm.However, at approximately 1:45am on february 1, 2019 the log file captured an active system alert:s3 alarm as a result of an active sf_ifd_shutdown_detected fault.As a result of this event pump speed dropped to 3200rpm and the flow reading became blank at 0lpm.Soon after the console alarmed with an set pump speed not reached:m5 alarm.Attempts to adjust pump speed were unsuccessful and the flow remained at 0lpm until the console was powered down.The console was evaluated and tested by the service depot.The reported issue could not be duplicated during their evaluation.The console was tested for an extended period of time along with its related motor (serial number (b)(4)) and flow probe as well as with a test motor.The console operated as designed at all speeds without any issues or flow blanking being reproduced.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.Additionally, routine battery maintenance was performed successfully.The returned console functioned as intended during the investigation.As a result, the root cause of the reported issue could not be conclusively determined.The tested unit was returned to the customer site.Reports of similar events are being tracked and monitored.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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 8375717
• MDR Text Key: 137316193
• Report Number: 2916596-2019-00903
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6473984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 02/10/2020
• Supplement Dates FDA Received: 05/21/2019; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 132