MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problems Insufficient Flow or Under Infusion (2182); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2019

Event Type  Injury  

Manufacturer Narrative

Multiple attempts were made to obtain patient information however none was provided.Date of event was estimated.Multiple attempts were made to obtain event date, however none was provided.Serial number of the devices was requested but not provided.No further information was provided.A supplemental report will be submitted when the manufacture's investigation is completed.

Event Description

It was reported a humming noise was heard from the motor.Centrimag gen 2 monitor showed decreasing flow unresponsive to clinician¿s attempt to increase flow.Flow continued to decrease resulting in patient composition.Patient clamped off ecmo and converted to back up motor.Flow resumed without further issue.

Manufacturer Narrative

Section d4: additional information.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag motor used during the reported event was not returned for analysis.Multiple attempts for product return were made but the motor was not returned.As a result, the reported event could not be confirmed and the root cause could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual section 3.1.5-"centrimag and pedivas blood pumps" states "the blood flow is dependent upon the amount of blood entering the pump, the pump speed (rpm), the extracorporeal circuit resistance, and drainage and return blood pressures.The relationship between pressure and flow rate as a function of rpm can be seen in figure 16 for a complete centrimag vas circuit (including the pump, tubing, and one representative set of cannulae that may be used with the pump)." this document also 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8771171
• MDR Text Key: 150391908
• Report Number: 2916596-2019-03291
• Device Sequence Number: 1
• Product Code: DWA
• 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: 11/06/2019

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: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 08/01/2019; 11/06/2019
• Supplement Dates FDA Received: 08/25/2019; 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1