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

Catalog Number 102956

Device Problem Device Stops Intermittently (1599)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

The referenced centimag console was reported under medwatch mfr report # 2916596-2018-02153.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was being supported with an extracorporeal circulatory support pump.It was reported that on (b)(6) 2018 at approximately 1700, the centimag console, paired with the centrimag motor, shut down while entering the elevator following extracorporeal membrane oxygenation (ecmo) application.During the brief moment the centrimag was off, the patient's blood pressure, and heart rate (hr) decreased.Once support was back on, the patient quickly recovered and was transported without further incident.The console and motor were exchanged.

Manufacturer Narrative

Device evaluation: the centrimag motor (serial number (b)(4)) used at the time of the reported event was not returned for analysis.The motor was disposed of by the customer.As a result, the reported event could not be confirmed, and the root cause of the event could not be conclusively determined during this investigation.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7545571
• MDR Text Key: 109293438
• Report Number: 2916596-2018-02144
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102956
• Other Device ID Number: 07640135140078
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 01/08/2019; 02/07/2019
• Supplement Dates FDA Received: 02/01/2019; 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening