MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS; PRIMARY CONSOLE WITH ADULT FLOW PROBE

Model Number 201-90401

Device Problem Overheating of Device (1437)

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

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is reporting the primary console.The motor is reported under medwatch mfr report # 2916596-2018-03893.The device is expected to be returned for analysis.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on extracorporeal circulatory support.It was reported that s3 and m6 error alarms occurred while in use supporting the patient.The motor head was observed to be very hot when the alarms were active.The pressure readings were not displayed.The primary console and motor/pump were exchanged safely, and the patient was stable and asymptomatic throughout the procedure which took approximately 80 seconds.The flow probe and pressure transducer were working on the spare primary console during the procedure.No additional information was provided.

Manufacturer Narrative

Section d10: additional information.Section h3: additional information.Section h4: additional information.Manufacturer investigation conclusion: the reported s3 and m6 errors were confirmed through the evaluation of the log file data downloaded from the returned centrimag 2nd generation primary console, however, no device-related issues were discovered during the evaluation of the returned primary console and a specific cause for these errors could not be conclusively determined through the investigation of the returned device.The returned primary console was evaluated by abbott technical services personnel under work order (b)(4).The reported s3 and m6 alerts as well as blank pressure readings were not reproduced during testing.The returned console was tested with the returned motor and flow probe used during the reported event.The unit ran multiple times and no error messages were produced.No issues were found during the evaluation of the returned components.The ous centrimag vad ifu (document pl-0266, rev.02) cautions the user to always have a spare centrimag vad, centrimag back-up console and spare equipment readily available for change.The centrimag motor ifu (document pl-0069, rev.04) cautions the user to have a spare centrimag motor and back-up equipment available.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS
• Type of Device: PRIMARY CONSOLE WITH ADULT FLOW PROBE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7867366
• MDR Text Key: 119934974
• Report Number: 2916596-2018-03891
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 201-90401
• Device Catalogue Number: 201-90401
• Device Lot Number: 6310873
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1