MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Thrombus (2101)

Event Date 02/19/2020

Event Type  Injury  

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 a newborn patient was implanted on (b)(6) 2020 at (b)(6) center with venous-arterial extracorporeal membrane oxygenation (ecmo) and transferred to (b)(6) hospital.Supporting therapy including thrombo-concentrates and fibrinogen administered.The centrimag (cmag) system was stable on 2900 rpm with flow 290 - 300 mls/min.On (b)(6) 2020, the clinical team reported sudden decrease of generated flow up to 0 mls/min with stable rpm and a flow below minimum alarm; the return line was clamped and they tried to restart flow by decreasing and increasing rpm with an open return line.There was no improvement so the cmag circuit was transferred to a backup centrimag console and motor, but there was no noted improvement.The new cmag circuit was exchanged with the removal of a small thrombi from the arterial cannulae (return).Support therapy was continued, including thrombo-concentrates and fibrinogen administration.On (b)(6) 2020, the clinical team reported sudden decrease of generated flow up to 0 mls/min with stable rpm and a flow below minimum alarm; the return line was clamped and they tried to restart flow by decreasing and increasing rpm with an open return line.There was no improvement, so a new maquet pls ecmo circuit was exchanged with the removal of a small thrombi from the arterial cannulae (return).The patient continued to receive therapy without any event and elective decommissioning of ecmo on (b)(6) 2020.Both the initial cmag system and backup cmag system had to be exchanged due to low flow.This event is also reported under mfr #2916596-2020-01175, mfr# 2916596-2020-01174, mfr#2916596-2020-01177.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of flow below minimum alarms was confirmed.However, per additional information received on 30jun2020, the reported event was not device-related.Log files were extracted from the returned centrimag consoles and were reviewed.F3: flow below minimum alarms were observed throughout 19feb2020 and 20feb2020.Flow values were observed to range from -0.006 to 0.012 lpm during the alarms, indicating that the console was still measuring flow as intended.On 20feb2020 at 17:42, the motor was observed to have been intentionally stopped to perform the reported console exchange.However, the flow probe and both pressure transducers were not observed to have been disconnected.The primary centrimag console was observed to alarm with f2: flow signal interrupted and f3: flow below minimum alarms after the patient had switched to the backup console due to the flow probe and pressure transducers remaining on the primary console.From the backup centrimag console¿s log file, an f2: flow signal interrupted alarm was observed on 20feb2020 at 17:44 when the console was powered on.This was due to the flow probe still being connected to the primary console, and as a result, flow reading was not observed in the log file of the backup console.On 20feb2020, the motor speed was observed to have been changed several times between 17:45 ¿ 17:52, with flow values always reading 0 lpm.Throughout all events within the timeframe of the reported event, the system operated at appropriate motor speeds within both log files, even during all flow below minimum and flow signal interrupted events.No other notable events were observed.The returned centrimag console was functionally tested on 08apr2020 and was found to perform as intended.No atypical events occurred throughout all testing.The serviced console was returned to the customer site after passing all testing per procedure.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: 9785196
• MDR Text Key: 184058583
• Report Number: 2916596-2020-01176
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

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 Model Number: 201-90401
• Device Lot Number: 6525865
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG CONSOLE, FLOW PROBE (S/N: (B)(6).; CENTRIMAG MOTOR (S/N: (B)(6).; CENTRIMAG MOTOR (S/N: (B)(6).
• Patient Outcome(s): Hospitalization; Required Intervention