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

Model Number 102956

Device Problem Overheating of Device (1437)

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

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

This report is against the motor.The console is reported under mfr.Report #2916596-2019-02587.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the generation 2 primary console stopped functioning due to an overheated motor.The console and motor were exchanged.The device was in use on a patient but no adverse patient consequences were reported.No additional information was provided.

Manufacturer Narrative

Section h3, h4, h9: additional information.Manufacturer's investigation conclusion: the report of a console issues and blank screen was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console associated with this event.Per the log file, on (b)(6) 2019 the console was supporting a pump at a speed of ~5200rpm and a flow of ~4.3lpm and the system was up for over 210 hours.At approximately 11:56pm on (b)(6) 2019 the log file captured an active system alert:s3 fault which was triggered by an active sf_ifd_shutdown_detected fault (dark screen), confirming the reported event.Following this event speed dropped to ~4700rpm and the flow reading became blank in the log file with a reading of 0lpm.Although there was no flow reading, flow would have continued to be present in the circuit.The log file then captured active pump speed not reached:m5 and flow signal interrupted:f2 alerts as well as pressure 1 below minimum:p4 and pressure 2 below minimum:p5.The flow signal remained blank until the console was powered down at ~12:17am.The log file did not capture any events which would indicate that the motor overheated.As a result, the report of this issue could not be confirmed.The returned centrimag motor was evaluated and tested by the service depot.The reported issue was not duplicated during their evaluation.The motor was operated for an extended period of time with its related 2nd gen primary console and flow probe.The motor was also tested with a test console and flow probe.During both tests the motor did not overheat at any point and always maintained proper flow.No error messages were reproduced during testing.The motor was functionally tested per the centrimag motor service process and the unit passed all tests.The returned motor functioned as intended during testing.However, reports of similar events have been documented and corrective action (capa) has been initiated to investigate and address the issue.This investigation has determined that the event was related to the motor used at the time of the event.Similar reports have also been associated with reports of the motor operating at a high temperature, consistent with reported information.Reports of similar events will continue to be tracked and monitored.The disposition of the motor will be determined by the capa.The 2nd generation centrimag system operating manual warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8713500
• MDR Text Key: 148462581
• Report Number: 2916596-2019-02588
• 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
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

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: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1