MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-90401

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is reporting the primary console.The motor is reported under medwatch mfr report # 2916596-2018-04058.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on extracorporeal circulatory support.It was reported that noise and high temperature occurred on the motor.The equipment was stored close to the bed on its cart.The motor was connected to the motor bracket and to the cart.The motor was at room temperature, and nothing relevant was close to the motor.During the event, the revolutions per minute (rpm) and flow were not adjusted very high.Reportedly, the equipment was handled 95% of the time by experienced hospital staff.At night, it is possible that nurses without a considerable amount of experience are checking the primary console.The motor was exchanged.Reportedly, there was no adverse consequence to the patient.No additional information was provided.

Event Description

Additional information: the centrimag equipment is stored close to the bed on its cart.The motor is connected to the motor bracket and to the cart.The motor is at room temperature, around 23c.Nothing relevant is close to the motors.Working points is around 1.600rpm for pediatric and for 0.9lpm for adult.During the events, the rpm and flow were not adjusted very high.Regarding if any new hospital staff has handled the 2nd gen equipment, it was answered that especially in the night, it can happen that no big experience nurses are checking the console.This hospital is working with centrimag console for more than 15 years, 2nd generation console from 4 years.The equipment was handled 95% by experienced staff.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8040526
• MDR Text Key: 127898144
• Report Number: 2916596-2018-04529
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

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: 201-90401
• Device Catalogue Number: 201-90401
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1