MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30105

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/16/2020

Event Type  malfunction  

Manufacturer Narrative

Patient initials and patient weight were requested, but not provided.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 in the operating room for a lung transplant.Once they were ready to perfuse the lungs the patient needed to go on extracorporeal membrane oxygenation (ecmo).Upon initial cannulation the femoral artery and aorta were dissected.This is the first time the circuit was used on the patient.The patient went back on bypass and the cmag circuit was thrown away because it was stagnant when the patient went back on bypass.When the patient was ready to go back on ecmo for a second time, they felt like the could not get adequate flow, the patient was bleeding and they were giving a lot of volume so they went back on bypass.There was also a lot of air in the circuit on the second go around.Once they were going on ecmo a third time they decided to just switch to a rotoflow device and everything went perfectly.The only alarms were low flow alarm setting and the intentional stopping and removing the pumps.Related manufacturer reference number for motor: 3003306248-2020-00079.Related manufacturer reference number for console: 3003306248-2020-00080.Related manufacturer reference number for blood pump: 3003306248-2020-00082.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of atypical flow reading issues/alarms was confirmed.A log file was extracted from the returned centrimag console (serial number (b)(6)) and was reviewed.Throughout data observed on (b)(6) 2020, the reported event date, flow reading was observed to be below average after several minutes of use following manually inputted pump speed changes, ranging between 0.001 ¿ 0.004 lpm.F2: flow signal interrupted and f3: flow below minimum alarms were also observed during several of these events.The centrimag motor was observed to have been exchanged/reconnected on (b)(6) 2020 at 7:37 (an m3: pump not interested alarm was observed and cleared), and the issue continued to persist.The system was observed to have been manually shut down at 8:04 on this date.However, the console was observed to have been in patient use again on (b)(6) 2020, and no flow reading issues occurred during that time while the unit operated at ~2900 ¿ 3700 rpm throughout the recorded events.The returned centrimag flow probe (serial number (b)(6)) was functionally tested alongside the returned centrimag console and motor under work order # (b)(4) on 18sep2020 and was found to perform as intended.The flow reading was not observed to have dropped at any point and no atypical alarms were reproduced.A full functional checkout was performed, and the unit was returned to the customer site after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual section 4-"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-"emergency / 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-"appendix i - primary console alarms and alerts" contains a list of console alarms and alerts, including f2 and f3 alarms, 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

Corrected investigation conclusion: the reported event of atypical flow reading issues/alarms was confirmed.A log file was extracted from the returned centrimag console (serial number (b)(6)) and was reviewed.Throughout data observed on 16aug2020, the reported event date, flow reading was observed to be below average after several minutes of use following manually inputted pump speed changes, ranging between 0.001 ¿ 0.004 lpm.F2: flow signal interrupted and f3: flow below minimum alarms were also observed during several of these events.The centrimag motor was observed to have been exchanged/reconnected on 16aug2020 at 7:37 (an m3: pump not inserted alarm was observed and cleared), and the issue continued to persist.The system was observed to have been manually shut down at 8:04 on this date.However, the console was observed to have been in patient use again on 24aug2020, and no flow reading issues occurred during that time while the unit operated at ~2900 ¿ 3700 rpm throughout the recorded events.The returned centrimag flow probe (serial number (b)(6)) was functionally tested alongside the returned centrimag console and motor on 18sep2020 and was found to perform as intended.The flow reading was not observed to have dropped at any point and no atypical alarms were reproduced.A full functional checkout was performed, and the unit was returned to the customer site after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual section 4-"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-"emergency / 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-"appendix i - primary console alarms and alerts" contains a list of console alarms and alerts, including f2 and f3 alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that another ecmo circuit was associated with this event.Related mfr report number for console: 2916596-2020-04412, related mfr report number for motor: 2916596-2020-04413.

• Brand Name: EM-TEC ADULT FLOW PROBE
• 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: 10520597
• MDR Text Key: 245925579
• Report Number: 3003306248-2020-00081
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: 07640135140108
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30105
• Device Catalogue Number: 201-30105
• Device Lot Number: 6786566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG BLOOD PUMP; CENTRIMAG MOTOR, US, SN: (B)(6); CENTRIMAG PRIMARY CONSOLE, SN: (B)(6)
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR