MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problems Communication or Transmission Problem (2896); Pumping Problem (3016)

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

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

The reported console event was reported under mfr# 2916596-2019-01504.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was being supported by the centrimag console which was running a centrimag pump.It was reported that the cmag console went blank and the pump stopped.They are unsure what caused this to happen and would like the console and motor evaluated and repaired if needed.No additional information provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported centrimag system failure was confirmed through the evaluation of the log file data downloaded from the returned centrimag 2nd generation primary console which showed that an s3 alert was recorded in addition to a speed reduction of almost 1000 rpm and flow readings of 0 lpm.However, the report of a pump stoppage was not confirmed.The log file retrieved from the 2nd generation primary console contained data from the time of the reported event on (b)(6) 2019.At the time of the reported event, the console was operating a motor at approximately 4100 rpm with a flow of approximately 3 lpm.On (b)(6) 2019 at 9:05 am, the log file captured an active s3 (system alert) alert followed by a reduction in pump speed to approximately 3350 rpm and an associated active m5 (pump speed not reached) alert.During this event, the flow reading reduced to 0 lpm.Pump speed subsequently increased slightly and remained at approximately 3450-3650 rpm with a flow reading of 0 lpm until the motor was disconnected and the pump was removed from the system at 9:07 am.During the s3 and m5 alerts, no full pump stoppage events occurred.The console continued to support the system but at a reduced speed of approximately 3350-3650 rpm.The returned centrimag motor was evaluated and the reported complaint was not duplicated.The returned motor was tested with the returned 2nd gen primary console and flow probe used during the reported event and the system was allowed to run for an extended period of time including overnight.There were no disruptions in the set rpms or flow values at any point and no errors or alarms were produced by the system.The motor cable was also inspected and no issues were found.A full functional checkout was performed and the unit passed all tests.The returned products were found to function as intended and the motor was returned to the customer site.Although the reported event could not be reproduced during testing of the returned equipment, this failure mode has been previously investigated and was determined to be an issue with the motor digital potentiometer.A capa was opened to investigate the issue.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

The device did not return.The complaint investigation determined the reported difficulty was the result of a design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8485003
• MDR Text Key: 141008432
• Report Number: 2916596-2019-01549
• 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: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• 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