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

Model Number 201-30300

Device Problem Pumping Stopped (1503)

Patient Problem Bradycardia (1751)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

This 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

It was reported that the patient was on extracorporeal membrane oxygenation (ecmo) support with no issues when the centrimag system suddenly alarmed and stopped working.The patient's blood pressure fell markedly and the patient became bradycardic.Inotropes were increased.The system was exchanged with the backup and after increasing the speed, the patient's condition stabilized.The patient was stable on ecmo in the icu for a few days before being transferred to another hospital.This report concerns the console.The motor is reported under mfr.#3003306248-2020-00004.

Manufacturer Narrative

Manufacturer's investigation conclusions: the reported event of the system stopping during use was confirmed; however, it was revealed that the centrimag console was unrelated to the cause of the event.The returned centrimag console (serial number: (b)(6) was functionally tested on 02apr2020.The console operated as intended when in use with a test centrimag motor.The serviced and tested console was returned to the customer site after all tests were performed per procedure.It was revealed that the root cause of the reported event was related to the returned centrimag motor.Review of the device history record for centrimag console s/n: (b)(6) showed the device was manufactured in accordance with manufacturing and qa specifications.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: 9715320
• MDR Text Key: 189323843
• Report Number: 3003306248-2020-00003
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other