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

Model Number 201-90411

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

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 had been connected to centrimag support for approximately 15 days, the patient was in right univentricular care.On (b)(6) 2019 the patient was claudica at the pulmonary level, so they turned on ventricular assistance.Later in the day, the account stated that the system was issuing an s3 alarm.The account acknowledged the alarm, however, the alarm did not go away.A new m6 alarm later occurred, the account sensed the system was heating up and exchanged to the backup system.No further information was provided.

Manufacturer Narrative

Section d3 and g2: correction.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d3, g2: correction.This report was later determined to be duplicate to manufacturer report number 2916596-2019-00952.All investigation results were communicated under that report.Method, result, and conclusion codes captured in report number 2916596-2019-00952 manufacturer investigation conclusion: the reported events of system alert: s3 and motor over temp: m6 alarms were not confirmed.The centrimag 2nd gen.Primary console (serial number (b)(6) ) was not returned for analysis, and no additional files related to the console were associated with the reported event.The reported events of system alert: s3 and motor over temp: m6 alarms were not confirmed via the investigation performed on the returned centrimag motor (serial number (b)(6) ).No further issues have been communicated at this time.The root cause of the alarms was unable to be determined through this analysis.No further information was provided.The manufacturer is closing the file on the 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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 9304735
• MDR Text Key: 166150331
• Report Number: 2916596-2019-05120
• 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: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 02/19/2020; 03/19/2020
• Supplement Dates FDA Received: 03/11/2020; 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1