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

Model Number 201-10002

Device Problems Mechanical Problem (1384); Overheating of Device (1437); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer reference number: 3003306248-2020-05464.It was reported that patient was under extracorporeal membrane oxygenation (ecmo) support with centrimag blood pump.The perfusionist heard an audible alarm (m4) and saw the motor was very hot and making a noise.Then perfusionist immediately replaced the pump for the backup controller and motor.Additional information states perfusionist also mentioned a noise when approaching the pump, it was a standard procedure to switch the cmag pump for backup motor and console.Patient had no symptoms and will continue with ecmo support.The pump was not exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of an m4: motor alarm along with the motor becoming hot to the touch and making atypical noises were not confirmed.The centrimag motor (serial number (b)(6)) was not returned for analysis, and no log files were associated with the reported event.The root cause of the reported events was unable to be determined through this analysis.Review of the device history record for centrimag motor, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa 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: 10849563
• MDR Text Key: 217151160
• Report Number: 3003306248-2020-05465
• 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: 04/23/2021

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: 201-10002
• Device Lot Number: 7474348
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE