MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Catalog Number 201-90411

Device Problems Overheating of Device (1437); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is reporting the console.The motor is reported under medwatch mfr report #2916596-2018-05346.Patient information was not provided.The centrimag console is not a single use device.Approximate age of the device is unknown.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was started on extracorporeal circulatory support on an unspecified date.It was reported that an m5 and s3 alarm was received on the centrimag (cmag) console.The cmag console was reported to be extremely hot to the touch and went completely blank.Despite the alarms and hot cmag console, the cmag motor continued to run and the monitor remained on.It was reported that flow could not be read as both the cmag console and monitor were reflecting only dashes.In addition, the motor speed could not be changed.Due to the event, the cmag console and cmag motor were exchanged and the issue resolved.Additional information was requested, but not yet provided.

Event Description

Additional information: patient was started on cmag on (b)(6) 2018.Patient did not undergo any additional treatment.Patient was stable during the motor and console exchange.Patient was weaned from ecmo and is doing well at home.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8113422
• MDR Text Key: 128713490
• Report Number: 2916596-2018-05347
• 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
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 93