MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EMTEC PEDIATRIC FLOW PROBE, OUS; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90701

Device Problem Failure to Align (2522)

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

Event Date 12/23/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device: will be provided upon investigation closure.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a centrimag device on an unspecified date.It was reported that both centrimag 2nd generation consoles experienced a "pump not inserted error" while in use on a patient.Circuit lines were checked for occlusions.The pump head was checked for correct placement to motor.The pump head was removed and re-seated in the pump motor; however, the alarm persisted.The account attempted to disable the alarm but it did not clear.The pump head was then inserted on a spare/back-up centrimag motor with a different console, bi-ventricular assist commenced immediately, and returned to full flow.No injury nor adverse outcome was a result of the event.No further information was provided.

Manufacturer Narrative

Sections e1, h4: additional information.Section f9: approximate age of device ¿ 1 year, 1 month from manufacture date to event date.Section h5: correction.

Manufacturer Narrative

Section d10: additional information section h3: additional information.Manufacturer investigation conclusion: the report of a "pump not inserted" error was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console.Per the log file, at approximately 3:13pm on (b)(6) 2018, per the timestamp, the log file captured a system alert:s3 alarm as a result of an active sf_ifd_shutdown_detected fault.During this event speed remained at ~4100rpm but the flow became blank at 0lpm.Soon after, multiple pump not inserted:m3 and motor alarm:m4 alarms were observed, consistent with reported information.The root cause of these alarms could not be conclusively determined based on the log file analysis.The returned console was evaluated and tested by the service depot.The reported issue could not be verified nor duplicated during testing.The console was tested for an extended period of time with both a test motor and flow probe as well as with its related motor evaluated and flow probe.The console performed as intended and no "pump not inserted" errors nor any other alarms were reproduced at any point.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 events captured in the log file could not be conclusively determined nor correlated to a console related issue.The console was due for its routine battery maintenance, which was performed successfully.The serviced and tested console 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 WITH EMTEC PEDIATRIC FLOW PROBE, OUS
• 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: 8450494
• MDR Text Key: 139800092
• Report Number: 2916596-2019-01296
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 201-90701
• Device Catalogue Number: 201-90701
• Device Lot Number: 6224747
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention