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

Model Number 201-90411

Device Problem Overheating of Device (1437)

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

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device- 2 days.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2019 it was reported that the centrimag motor had a audible noise and it was felt that the motor temperature was hotter than usual.On (b)(6) 2019, the system alerted that m6 system motor over temperature was alarming.The healthcare providers initiated a controller system exchange to the backup system and reinstituted support.The patient was stable through the whole process.No further or additional information was provided.

Manufacturer Narrative

The centrimag motor was captured under mfr# 2916596-2019-03776.H4: additional information.Manufacturer's investigation conclusion: the reported event of a m6 alarm was confirmed via the log file.The centrimag 2nd generation primary console was returned for analysis and a log file was downloaded from the console for review.A review of the downloaded log file showed events spanning approximately 526 days (b)(6) 2019¿ (b)(6) 2019per time stamp).The console was running a motor at a speed of ~3800 rpm with a flow of ~3.6 lpm.On (b)(6) 2019 at 19:21, a sub fault ¿sf_lmc_motor_high_temperature¿ activated and triggered a ¿motor over temp: m6¿ alarm.The alarm was able to be muted in the same time stamp.At 19:25, the pump was disconnected, and the system was turned off at 19:26.The console was forwarded to the service depot for analysis and was evaluated and tested.The reported event of an audible noise from the motor as well as the a m6 alarm and the motor being hotter than normal was not able to be duplicated or verified.The console was tested for an extended period of time with the returned and associated motor as well as a lab test motor and flow probe.No abnormal noise or high temperatures were observed.No m6 alarm or any other alarms were present at any point.The console functioned as intended.A full functional checkout was performed, and the unit passed all tests.A successful battery maintenance was performed to the console¿s battery.The console was returned to the customer.The root cause for the reported event was not conclusively determined through this analysis.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" 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." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." 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.The 2nd generation centrimag system operating manual section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.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 CH-80 05; SZ CH-8005
• MDR Report Key: 8887196
• MDR Text Key: 154100471
• Report Number: 2916596-2019-03783
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6398773
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 10/21/2019; 10/21/2019
• Supplement Dates FDA Received: 10/22/2019; 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 136