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

Model Number 201-90411

Device Problem Decreased Pump Speed (1500)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

No patient information was provided.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

Related manufacturer report numbers: 2916596-2021-04342, 2916596-2021-04343, and 2916596-2021-04344.It was reported that the patient was placed on venovenous (vv) extracorporeal membrane oxygenation (ecmo) with centrimag on (b)(6)2021.The centrimag settings were 5400 revolutions per minute (rpm) and 6.86 liters per minute (lpm).There was a circuit exchange to a different console on (b)(6) 2021.The centrimag settings were 5400 rpm and 6.93 lpm.The customer site reported that they were unable to get to 5500 rpm with the patient on two different consoles.Two circuit exchanges and two different centrimags were able to get the patient to 5450 rpm highest.On (b)(6) 2021 the patient was decannulated and the system was available for evaluation.The centrimag console and centrimag motor were placed on the hospital's primed circuit and 5500 rpms was achieved for over two hours.The hospital site could not reproduce the event.There were no alarms through the duration of the run.

Manufacturer Narrative

Correction: the initial report was incorrectly submitted with a cfn-based manufacturer (mfr) report number: 2916596-2021-04345.The mfr number should have been fei-based with the 10 digit fei being 3003306248.Manufacturer's investigation conclusion: the reported event of the centrimag system being unable to reach and operate at 5500 rpm was not confirmed.The centrimag console (serial number unknown) was not returned for analysis, and no log files from this console were provided.Questions regarding the console¿s information and return status were asked multiple times and no responses were received.The root cause of the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual section 8 ¿system operations¿ instructs users on how to adjust the system¿s set speed by using the centrimag console¿s interface.Slowly increase the rpm until the flow rate is at the desired level.Section 6.7 ¿operator controls¿ also describes how to use the console¿s interface to adjust pump speed.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report numbers: 2916596-2021-04342, 2916596-2021-04343, 2916596-2021-04344, and 3003306248-2021-04039.It was reported that one centrimag blood pump and tubing were also exchanged due to the patient's positive yeast cultures.

• 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
• MDR Report Key: 12263649
• MDR Text Key: 264783918
• Report Number: 2916596-2021-04345
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1