MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number L201-90411

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

This event is also reported under mfr #2916596-2019-04393.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 patient was being transferred back to patient bed.When moving the equipment back to patient bed, the nurse hears and notices alarm with 0.0 lpm flows on the console.Different nurses checked connections for centrimag (cmag) flow probe, motor, and disposable housing was proper.Felt and visualized the motor and noticed no movement.Dark blood was observed in extracorporeal membrane oxygenation (ecmo) lines.The motor and console was immediately switched to a 2nd generation equipment set.Flow was reestablished, and the patient was not compromised.The second down incident was less than 5 minutes.A perfusionist tested the exchanged equipment."pump not inserted: m3" and "system alert: s3" was observed when testing the set.Same alarms appeared when the motor was interchanged with another working motor even when turned on and off.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of alarms and interruption in pump support was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console (sn (b)(6)) per the log file, the console was powered on at ~12:06am on september 4, 2019.Soon after being powered on the console was captured as operating on battery support.Speed was set to 4200rpm and the system responded as designed.Speed was captured at ~4200rpm and flow was captured at ~5.1lpm.The console continued to support the system as designed until ~12:17am when the console alarmed with flow signal interrupted:f2 and motor disconnected:m2 alarms and both the speed and flow readings dropped to 0.Within 1 minute the console alarmed with a system alert:s3 alarm as a result of an active sf_lmc_supply_5v_motor fault.This alarm cleared on its own soon after, but speed remained at 0rpm until the console was powered down at ~12:21am on september 4, 2019.The returned centrimag 2nd gen primary console (sn (b)(6)) was evaluated and tested by the service depot.The reported complaint could not be duplicated nor verified during their evaluation.The console was tested for an extended period of time with a test motor and the returned flow probe (sn (b)(6)) associated with this complaint without any issues being reproduced.The console was then functionally tested per the centrimag 2nd gen primary console service process and the unit passed all tests.Additionally, battery maintenance was performed successfully.The tested unit was returned to the rental pool.The console was not tested with the returned centrimag motor (sn (b)(6)) because the motor was found to be defective and the root cause of the reported event.The motor is reported under mfr #2916596-2019-04393.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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: 9104731
• MDR Text Key: 161450045
• Report Number: 2916596-2019-04391
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: L201-90411
• Device Lot Number: 6329351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2019
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 101