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

Model Number 201-90411

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2018

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 was returned for analysis.Evaluation is not complete.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient is supported by an extracorporeal circulatory support device.It was reported that the primary console generated an s3 error code that the bio-med engineer could not clear after using the acknowledge button.The primary console is being returned for repair.The s3 error code did not affect pump speed or patient support.

Manufacturer Narrative

Section h4: additional information.Section d8: the centrimag primary console is not a single use device.Section f9: approximate age of device - 3 years, 2 months.Investigation conclusion: the report of an s3 alarm was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console (serial number (b)(4).The log file contained approximately 29 days of data (dated (b)(6) 2018 - (b)(6) 2018, according to the timestamp).Per the log file, the system was operating for over 139 hours.At approximately 3:11pm on (b)(6), 2018 the log file captured an active system alert: s3 alarm.During this time the system was operating at approximately 4500rpm.Attempts to adjust the speed to 5500rpm were unsuccessful.However, when speed was set to 4400rpm and later to 4200rpm, the system responded as designed.At approximately 3:29pm the log file captured an active motor over temp: m6 alarm.Approximately 4 minutes later speed was set to 0rpm and both the system alert: s3 and motor over temp: m6 alarms cleared.The system was powered down soon after.The returned centrimag 2nd gen primary console was evaluated and tested by tech service under work order # (b)(4).The console was tested along with its related motor (serial number (b)(4), evaluated under (b)(4) and flow probe (serial number (b)(4), evaluated under (b)(4).The system was operated multiple times and no error messages or any other functional issues were reproduced.As an additional observation, during testing it was noted that the internal battery (serial number (b)(4).Had expired on (b)(6), 2017.The expired battery was replaced with a new one.Battery maintenance was performed successfully.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.The returned console was found to function as intended.As a result, the root cause of the reported issue could not be conclusively determined.The serviced and 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: 8114213
• MDR Text Key: 129078075
• Report Number: 2916596-2018-05106
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• 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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2019
• Patient Sequence Number: 1