MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number L102956

Device Problem Vibration (1674)

Patient Problem Thrombus (2101)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

A separate report has been filed capturing the blood pump, reported under mfr # 2916596-2019-02958.Approximate age of device- the centrimag motor is not a single use device.The amount of time the device was in use supporting this patient was 28 days.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 ventricular circulatory assist system starting on (b)(6) 2019.It was reported the centrimag motor was making intermittent noise described as grinding sound.No alarms were reported.There was no adverse patient impact.Because the sound was intermittent and no changes in flow were noted, no action was taken at the time.It was reported the patient would not tolerate a stop in support, therefore, the system was not exchanged.On (b)(6) 2019, the blood pump and motor were exchanged due to a suspected clot in the blood pump.The exchange occurred without complication and there was no adverse patient consequence reported.It was reported the noise has not resolved.The motor and blood pump will not be returned.The serial number of the blood pump is unavailable.No additional information was provided.

Manufacturer Narrative

Investigation summary: the report of a centrimag motor making intermittent grinding noise could not be confirmed during the investigation of the returned centrimag motor.The returned motor was evaluated and tested by the service depot.The reported issue of the motor making intermittent noise could not be confirmed nor reproduced during their testing.The motor was left running overnight without any issues with noise being observed.The motor was functionally tested per the centrimag motor service process and the unit passed all tests without any issues.As a result, the root cause of the reported event could not be conclusively determined during the investigation.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console, and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.No further information was provided.The manufacturer is closing the file on the event.

Manufacturer Narrative

Section d10: correction.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8734251
• MDR Text Key: 149186890
• Report Number: 2916596-2019-03032
• Device Sequence Number: 1
• Product Code: KFM
• 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,user faci
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L102956
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 09/13/2019; 09/18/2019; 09/18/2019; 09/18/2019; 02/10/2020
• Supplement Dates FDA Received: 09/17/2019; 09/18/2019; 09/18/2019; 09/18/2019; 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 15