MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-10002

Device Problems Overheating of Device (1437); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2019

Event Type  malfunction  

Manufacturer Narrative

Per instruction for use (ifu), both cmag motor and console needs to be switched to a backup system if there is an issue.This event is also reported on a cmag console (s/n: ) under mfr #2916596-2019-05634.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that there was a strong noise in the centrimag (cmag) motor during the assistance and a high temperature elevation.The motor was switched to a backup motor that worked normally.There was no further issue.The patient was discharged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of the centrimag motor heating up and creating loud noises were not confirmed.The returned centrimag motor was tested on 17dec2019.The motor was functionally tested and was found to perform as intended.The root causes of the reported events were unable to be determined through this analysis.Review of the device history record for centrimag motor s/n (b)(6) showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The centrimag motor ifu in section titled "warnings," indicates that the motor may feel warm to the touch.Overheating is confirmed by a motor over temp console alert message and temperature sufficient to prevent the user from placing and holding a hand on the motor housing.Clamp the return tubing and switch to the backup system.The labeling has an emergency/troubleshooting section for the primary 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 to continue patient support.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9445874
• MDR Text Key: 170106526
• Report Number: 2916596-2019-05508
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Device Lot Number: 6910047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1