MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device - the centrimag motor is not a single use device.Approximate age of the device is 14 days.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

Extracorporeal membrane oxygenation (ecmo) started on (b)(6) 2019.It was initially reported that cmag console display went blank and it was unsafe to use.However, additional information was received where it was reported that the screen came back on once 'the force stop' button was pressed to switch to the backup.Motors were tagged and held at first but were eventually exchanged because they likely to have caused it.Patient was asymptomatic.

Manufacturer Narrative

The centrimag devices used during this event were not returned for analysis.No log files or pictures were submitted for the event.As a result, the reported event could not be confirmed and the root cause could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual (doc.# (b)(4) and # (b)(4) has an emergency/troubleshooting section for the 2nd generation 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.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 the event.

Manufacturer Narrative

Section d3, g1, g2: correction.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8757780
• MDR Text Key: 149932942
• Report Number: 2916596-2019-03213
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 07/31/2019; 02/10/2020
• Supplement Dates FDA Received: 08/08/2019; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 83