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

Model Number 201-90411

Device Problem Device Stops Intermittently (1599)

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

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

The patient weight was requested but not provided.Approximate age of device - the centrimag primary console is not a single use device.Approximate age of the device is 5 days.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 (b)(6) 2018.It was reported that a centrimag console alarm was observed on (b)(6) 2018.The console was exchanged since the alarms did not resolve.The patient came off extracorporeal membrane oxygenation (ecmo) on (b)(6) 2018 successfully.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the cmag console was returned for evaluation.The report of s3 alarms on (b)(6) 2018 could not be confirmed during the investigation of the returned centrimag 2nd gen primary console.The reported complaint was not verified nor duplicated during testing.The unit was operated multiple times and no error messages or issues were observed during testing.Full functional checkout was performed and the unit passed all tests.The console was found to function as intended.As a result, the root cause of the reported event could not be conclusively determined nor correlated to a console related issue.Reports of similar events will continue to be tracked and monitored.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Device manufacture date: correction.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich ; SZ
• MDR Report Key: 7556385
• MDR Text Key: 109628372
• Report Number: 2916596-2018-02249
• 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,Followup
• Report Date: 02/24/2019

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: Lay User/Patient
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Other Device ID Number: 7640135140702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 11/08/2018; 12/14/2018; 02/11/2019
• Supplement Dates FDA Received: 11/28/2018; 01/04/2019; 02/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 MO