MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30300

Device Problems Overheating of Device (1437); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2019

Event Type  Injury  

Manufacturer Narrative

Per instruction for use (ifu), both cmag motor and console needs to be switched to a backup system if there is an issue.This event is also reported on a cmag motor (s/n: ) under mfr #2916596-2019-05508.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that there was a strong noise in the centrimag (cmag) motor during the assistance and a high temperature elevation.The motor was switched to a backup motor that worked normally.There was no further issue.The patient was discharged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag console (serial number (b)(4)) was not returned for analysis.No log files associated with the reported event were provided.All atypical events were addressed via the centrimag motor¿s investigation (serial number (b)(4), evaluated under mfr #2916596-2019-05508).As the console was not returned, the root cause of the reported event was unable to be determined through this analysis.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 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9438984
• MDR Text Key: 170039460
• Report Number: 2916596-2019-05634
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Lot Number: L02305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1