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

Model Number 201-90411

Device Problems Failure to Power Up (1476); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2019

Event Type  malfunction  

Event Description

It was reported that centrimag (cmag) system flow stopped with corresponding "system failure" alarm on device.Cmag circuit transferred onto back up device.Device taken out of service and reported to supplier for diagnostic and repair if required.The cause of the event is unknown.This event is also reported under mfr #2916596-2020-00533.

Manufacturer Narrative

Manufacturer's investigation conclusion: the returned centrimag 1st gen primary console (sn (b)(6)) was evaluated and tested by the service depot under work.Visual inspection of the unit did not reveal any issues.The system was in good condition.However, upon opening up the console, 4 housing blocks were found to be broken.The root cause of this damage could not be conclusively determined.A functional test was performed and the system operated as intended.As a result, the reported event could not be confirmed nor reproduced.However, due to the 4 broken housing blocks the console was scrapped.The housing blocks provide connections to the console's grounded bottom plate.If these connections are no longer present the console's emc specification will no longer be met.The damaged housing blocks could not be correlated to the reported event as the console operated as intended during functional testing.Reports of similar events will continue to be tracked and monitored.Centrimag motor instructions for use (ifu) instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use (ifu) states "always have a spare centrimag blood pump, back-up console and equipment available for change out." centrimag primary console operating manual warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the primary console or primary motor experience a malfunction." 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: 9712573
• MDR Text Key: 180194364
• Report Number: 2916596-2020-00827
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR