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

Model Number 201-90411

Device Problem Visual Prompts will not Clear (2281)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

Information was not provided.Approximate age of device - the centrimag primary console is not a single use device.The device has been returned but has not yet been investigated.No further information is available at this time.A supplemental report will be submitted with the manufacture investigation is completed.

Event Description

It was reported that the primary console indicated a system alert (s3) alarm.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: this per was determined to be a duplicate to (b)(4) / per- (b)(4).The returned console was evaluated and tested under that complaint.The report of s3 alarms was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console (serial number (b)(4).Between 7:20am and 7:28am on (b)(6), 2018 the log file captured multiple system alert:s3 alarms.These faults cleared and re-occurred multiple times but they did not affect the console's ability to support the motor and pump at the set speed of 3900rpm.After the last alarm cleared at 7:28am no further issues were observed for the last hour of system operation.The s3 alarm reported to have occurred on (b)(6), 2018 could not be confirmed as newer events had overwritten the older events in the log file.The returned centrimag 2nd gen primary console (serial number (b)(4) was evaluated and tested by tech service under work order # (b)(4).The reported complaint was not verified nor duplicated during their testing.The unit was operated multiple times and no error messages or issues were observed during testing.Full functional checkout was performed per the centrimag 2nd gen primary console service process 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.New backup system warning label was applied per field action (b)(4) and the tested unit was returned to the customer site.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• 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: 8093018
• MDR Text Key: 128065047
• Report Number: 2916596-2018-05006
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• 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: 04/22/2019

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: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1