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

Model Number 201-90411

Device Problems Overheating of Device (1437); Pumping Stopped (1503); Communication or Transmission Problem (2896)

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

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

T was reported the centrimag console displayed a s3 alarm and the motor became very hot.The console, motor and circuit were all replaced.The patient remains on ecmo support.No further information reported.

Manufacturer Narrative

Manufacturer's 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.Per the log file, on may 18, 2019 the console was supporting a system at a speed of ~4500rpm and a flow of ~4.1lpm for over 106 hours.At approximately 5:21am on may 18, 2019 the log file captured an active system alert:s3 alarm as a result of an active sf_ifd_shtudown_detected fault (dark screen).During this event, pump speed dropped from ~4500rpm down to ~3300rpm and the flow reading became blank with a reading of 0lpm.However, flow would have continued to occur in the circuit.The console then alarmed with a set pump speed not reached:m5 and flow signal interrupted:f2 alarms.Attempts to adjust pump speed were unsuccessful.The system was stopped at approximately 5:31am and the pump was disconnected soon after.The flow reading remained at 0lpm until the console was powered down.The returned centrimag 2nd gen primary console was evaluated and tested by the service depot.The reported complaint was not duplicated during their evaluation.The console was operated for an extended period of time with its associated motor, evaluated under evaluated under mfr# 2916596-2019-02520) and flow probe as well as with a test motor.No s3 alarm nor any other atypical alarms were reproduced at any point during testing.Routine 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 events captured in the log file could not be correlated to a console related issue.The serviced and tested console was returned to the customer site.Although the reported event was not reproduced during testing, reports of similar events have been documented and corrective action (capa) has been initiated to investigate and address the issue.The investigation has determined that this event was caused by an issue with the motor used at the time of the event.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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 8651410
• MDR Text Key: 146413814
• Report Number: 2916596-2019-02519
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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 Expiration Date: 01/31/2019
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 5815596
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1