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

Model Number 201-10002

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is reporting the motor.The primary console is reported under medwatch mfr report # 2916596-2018-05624.The event occurred at (b)(6) hospital, (b)(6).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 membrane oxygenation (ecmo) support.It was reported that the pump suddenly stopped working.The healthcare professionals were able to get it to work again without having to exchange any equipment.The patient was not harmed or injured due to event.The patient remains stable on ecmo support.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusions: the reported event could not be confirmed and a root cause could not conclusively be determined through this evaluation.The centimag primary console operating manual states 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.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Updated manufacturer's investigation conclusions: the reported event could not be confirmed through the evaluation of the returned centrimag motor and a specific cause for the event could not conclusively be determined.After receipt, the returned motor was cleaned and disinfected.During the investigation of the returned motor, the reported faults could not be reproduced.The returned console and motor were operated together to try to reproduce the reported motor problem.During operation, the motor¿s cable was slightly bent bi-directionally in order to find out if a possible cable break or short circuit would occur.The motor operated as intended during the test and no shorts were reproduced.The system was operating at 3600 rpm with 3.3 lpm flow for 2 days and no errors or issues occurred.Visual inspection of the returned motor¿s cable did not reveal any findings of damage.The returned motor was sent back to the distribution center and returned to the customer.The review of the returned motors' dhr revealed that the motor passed all inspections and tests before being shipper to the distributor.No further information was provided.The manufacturer is closing the file on this event.

• 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: 8192725
• MDR Text Key: 131381694
• Report Number: 2916596-2018-05625
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1