MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problems No Flow (2991); Pressure Problem (3012)

Patient Problem Cardiac Arrest (1762)

Event Date 11/22/2022

Event Type  Death  

Event Description

It was reported that there was an event when using ecls with cardiohelp.It was reported "the paramedics arrived in the cath room telling us that the patient has been in acr since their arrival at home and that it's been 50 min of low flow (aesp and asystole).The patient arrived with the lukas fitted by the paramedics.He never had an own rhythm.The cardiohelp never really ran despite the increase in rpm.During the placement of the cannulas we did not stop the lukas.With the negative venous pressure alarm customer were never able to get the ecmo ¿motor¿ running." the cardiohelp was not exchanged during the reported event.Further information regarding the current health impact of the patient is pending complaint id: (b)(4).

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

Additional information received on 2022-12-01 that the patient had died anyway before his arrival in the cath room during surgical staff tried to put patient on ecmo.A follow up will submitted when additional information become available.

Manufacturer Narrative

It was reported the paramedics arrived in the catheter room telling that the patient has been in acr since their arrival at home and that it's been 50 min of low flow (aesp and asystole).The patient arrived with the lukas device fitted by the paramedics.The patient never had an own rhythm.The cardiohelp never really ran despite the increase in rpm.During the placement of the cannulas the lukas device was not stopped.With the negative venous pressure alarm the customer was never able to get the ecmo ¿motor¿ running.The cardiohelp was not exchanged during the reported event.No service was performed as the event happend due to patient conditions as confirmed by the customer.Further information was received by the getinge service and sales unit: - the medical team failed to start ecmo on a 49-year-old patient in cardiac arrest for 50 minutes under cardiac massage (lukas device), - the cannulas were placed under ultrasound control, arterial flow and venous flow at the end of the cannulas before connection to the circuit, - high negative venous pressure and pulsating venous line of the circuit ("chatter") is a sign of a lack of volume according to the customer and causes therefore an insufficient preload, "in settings of low central venous pressure or high pump speed, the negative pressure generated by the pump may cause venous collapse and a temporary decrease in blood flow.This can be visualized at the bedside as "chugging" (also referred to as "chatter") - priming longer than cannulation: some teams pre-prime the machine to be ready for an emergency but the machine can only stay primed for one month according to some feedback/studies from ecmo centers, this technique is not a getinge recommendation and is not part of ifu to date, so pre-priming remains the responsibility of the users.The event was analyzed by getinge medical affairs on 2023-02-27 with the following conclusion: "the evaluation of the described scenario resulted in the conclusion that the cardiohelp did not contribute to the reported expiration of the patient.The most likely explanation for the inability to start perfusion is the volume status of the patient in combination with a contracted vascular system due to long time resuscitation.The practicing doctor prof.Cook described that the expiration of the patient had been diagnosed before the patient arrived in the catheter laboratory.Therefore, the negative aspects of longtime resuscitation have to be taken into consideration as possible cause that made the use of cardiohelp difficult.Additionally the interplay of the lukas device and the cardiohelp could have complicated the situation, as the flow and pressure created by the lukas device could cause the cardiohelp to stop or go into backflow prevention as the flow is recognized retrograde through the ecls circuit.The article written by james m.Walter et al.Chugging in patients on veno-venous extracorporeal membrane oxygenation: an under-recognized driver of intravenous fluid administration in patients with acute respiratory distress syndrome.In this article, walter describes the following: contemporary ecmo devices use a centrifugal pump to generate a pressure gradient between the patient's venous circulation and the ecmo circuit, which drives blood flow.In settings of low central venous pressure or high pump speed, the negative pressure generated by the pump may cause venous collapse and a temporary decrease in blood flow.This can be visualized at the bedside as ¿chugging¿ (also referred to as ¿chatter¿) ¿ rhythmic pulsations of the ecmo tubing due to erratic flow.If left untreated, this may progress to fluctuations in the measured ecmo flows or complete flow cessation due to ¿suck-down.¿(1) according to prof.Cook as the attending physician, a lack of volume seems to have been contributory to insufficient preload.Therefore, a lack of sufficient patient volume (preload) may have contributed to the inability to start the perfusion with cardiohelp.Taking the available evidence in consideration, it does not appear that the product (i.E.Cardiohelp and its associated disposable) was subject to either an unexpected malfunction and/or defect or diminution in performance." according to the instruction for use (ifu) of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, chapter 4.3.1 safety instructions for the oxygenator) it is stated to always ensure that the patient has a sufficiently high hematocrit and volume.Moreover in the instruction of use (ifu) of the cardiohelp (chapter 9.3.1 high priority alarms)) it is stated that a possible cause for a below pressure could be medical grounds.Possible remedies are listed as volume administration as per volume status.The device was manufactured on 2015-03-06.The review of the non-conformities has been performed on 2023-03-03 for the period of 2015-03-06 to 2023-11-23.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.Based on the results no malfunction of the cardiohelp could be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe 2021-11-23 till 2022-11-23 ).The customer will be informed about the results by the getinge sales and service unit.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 15892875
• MDR Text Key: 304589880
• Report Number: 8010762-2022-00476
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Sex: Male