MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS; PRIMARY CONSOLE WITH ADULT FLOW PROBE

Model Number 201-90401

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 primary console.The motor is reported under medwatch mfr report # 2916596-2018-05625.The event occurred at (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

Section d10: additional information.Updated manufacturer's investigation conclusions: the reported event could not be confirmed through the evaluation of the returned centrimag console and a specific cause for the event could not conclusively be determined.After receipt, the returned console was cleaned and disinfected.A test monitor was then connected to the returned console, and the console was connected to a mains supply.The log file was then downloaded and analyzed.According to the images attached in to the complaint, the event occurred on (b)(6)2018; however, the log file analysis showed that the data from the event date was already overwritten.The data was then downloaded off the monitor; however, the data from the event date was also overwritten.During the investigation of the returned console, the reported faults could not be reproduced.The returned console and motor was 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 a 3600 rpm with 3.3 lpm flow for 2 days and no errors or issues occurred.The returned console was sent back to the distribution center.The review of the returned console's dhr revealed that the device passed all inspection and tests before being shipped to the distributor.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS
• Type of Device: PRIMARY CONSOLE WITH ADULT FLOW PROBE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8192714
• MDR Text Key: 131797725
• Report Number: 2916596-2018-05624
• 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,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

• 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: 5584897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 05/29/2019; 10/08/2019
• Supplement Dates FDA Received: 05/30/2019; 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1