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

Model Number 201-10002

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

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

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for analysis.It has not yet been received 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 motor was exchanged.Reportedly, there was no adverse consequence to the patient.No additional information was provided.

Manufacturer Narrative

Investigation conclusion: the reported event of high temperature and motor noise was not confirmed.The centrimag motor ((b)(4)) was returned for analysis at thoratec (b)(4) and evaluation by investigator (b)(4) under (b)(4).No faulty behavior was determined, and the motor operated as intended.The review of the returned motor¿s dhr revealed that the unit was manufactured in november 2017 and had a field time of around 9 months.A specific root cause for the reported high temperature was not conclusively determined through this analysis; however, the most probable reason is wrong installation of the pump by the user inside of the motor body.Abbott italy was briefly informed on how to install the pump correctly.The correct insertion of the pump into the motor is described in the centrimag motor instructions for use (doc.(b)(4)).Other possible root causes include blood clots in the pump, disruption of the natural convection of the motor, or thermal conduction by the transfer of heat from an external device.No further information was provided.The manufacturer is closing the file on this event.

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 1.600 rpm 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 MOTOR, OUS
• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7917244
• MDR Text Key: 122013557
• Report Number: 2916596-2018-04058
• Device Sequence Number: 1
• Product Code: KFM
• 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

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Device Catalogue Number: 201-10002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1