MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR; MOTOR, RENTAL

Model Number L102956

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

It 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

Section h10: the device returned for analysis.Similar reports has been investigated and the reported event was the result of a software design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott will perform a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The investigation will be submitted as a follow-up once it is complete.

Manufacturer Narrative

D3: correction g2: correction h3,h4, h7, h9: additional information manufacturer's investigation conclusion: the report of an s3 alarm was confirmed through the analysis of a data log file retrieved from the centrimag 2nd gen primary console associated with this event.Per the log file, on (b)(6) 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 (b)(6) 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 reported event was not reproduced during testing of the returned centrimag motor.However, reports of similar events have been documented and corrective action (capa) has been initiated to investigate the issue.The investigation has determined that this event was caused by a motor related issue.Final disposition of the motors will be determined by the capa.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 MOTOR
• Type of Device: MOTOR, RENTAL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8651422
• MDR Text Key: 146419066
• Report Number: 2916596-2019-02520
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• 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,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 Model Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• 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: 08/08/2019; 08/29/2019
• Supplement Dates FDA Received: 08/29/2019; 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention