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

Model Number 201-90411

Device Problems Overheating of Device (1437); Unexpected Shutdown (4019)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

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 centrimag's motor became very hot and shut off.The motor was switched with the backup motor and support was regained.It was also reported that the patient passed away.This event was related to manufacturer's report 3003306248-2020-00012.

Event Description

It was reported that the cause of the overheating and shut off was no identified.The patient was on ecmo for (12) days.His pulmonary condition continued to decline and the patient's family made him comfort care.It was also reported the death was not considered to be device related.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the motor overheating and shutting off was not confirmed.The centrimag 2nd generation primary console (serial#: (b)(6) was returned for analysis and a log file was downloaded from the console for review showing events spanning approximately 32 days (17feb2020 ¿ 20mar2020 per time stamp).On 18feb2020 at 18:32:00, the sub fault ¿ifd_shutdown_detected¿ activated and triggered ¿system alert: s3¿ and ¿set pump speed not reached: m5¿ alarms.The motor speed dropped to ~3200 rpm and the flow dropped to 0 lpm.The motor was disconnected at 18:40:00 and the console was powered off at 18:45:00.The centrimag 2nd generation primary console was evaluated and tested.The reported event of the motor becoming very hot and shutting off was not duplicated nor verified.The console was run for an extended period of time, including overnight, with the returned and associated motor and flow probe.There were no alarms or other issues observed.A full functional checkout was performed, and the unit passed all tests and will be returned to the customer site.Reports of similar events have been documented and corrective action had been initiated to investigate the issue further.The investigation has determined that the issue is not related to a 2nd generation primary console related issue.Reports of similar events will continue to be tracked and monitored.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.

Manufacturer Narrative

Section b1, b2, h1, and h6 (patient code): correction.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: 9818260
• MDR Text Key: 182944802
• Report Number: 3003306248-2020-00011
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• 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: 05/29/2020

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 Expiration Date: 01/31/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6804156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 05/29/2020; 05/29/2020
• Supplement Dates FDA Received: 05/29/2020; 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, US
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 82