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

Model Number 102956

Device Problems Inaccurate Flow Rate (1249); Nonstandard Device (1420)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

This event was previously under mfr # 2916596-2018-05579.The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date and unique identifier (udi) are unknown.The device has not returned for analysis.Similar reports has been investigated and the reported difficulty was the result of a design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott will perform a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The investigation will be submitted as a follow-up once it is complete.

Event Description

The patient was placed on biventricular extracorporeal circulatory support at an unspecified date.It was reported that the centrimag system produced a system alert (s3) and a set pump speed not reached alert (m5).Per report from staff, the pump had no flow during this period.The patient was switched over to a different centrimag console and motor.A user facility report (uf report# (b)(4)) for this event was received on 19dec2018 stating: "patient is centrally cannulated with centrimag with oxygenator.Centrimag began alarming s3 and m5.Flows dropped on screen.Mcs rn told patient rn to get cca.Mcs rn grabbed backup centrimag.Charge nurse also assisted in helping getting backup centrimag attached.Patient was probably flowless for 2-3 minutes.Cca arrived and we were able to get flows back to 6-5.9 lpm.Patient did become hypotensive during this event but once flows were achieved patient recuperated.Perfusion notified of system failure.2 more backs up brought from operating room.".

Manufacturer Narrative

Analysis conclusion: the centrimag motor used during the reported event was not returned for analysis.Multiple attempts requesting product return as well as additional information did not receive a response.As a result, the root cause of the reported event could not be conclusively determined.The reported event was confirmed during the investigation of the related 2nd gen primary console (sn (b)(6) reports of similar events will continue to be tracked and monitored.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.

• 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: 8946009
• MDR Text Key: 160894662
• Report Number: 2916596-2019-04221
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention