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

Model Number CARDIOHELP-I

Device Problems Infusion or Flow Problem (2964); No Flow (2991); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A medical review is ongoing.A follow-up emdr will be submitted when additional information becomes available.

Event Description

Following was initially reported: "after 6 hours of ecmo therapy, abrupt stop of the machine (there was an alarm message on the machine but the client does not remember the message) - cardiac arrest of the patient (ecmo va) cpr ¿ perfusionist present.The pump was running but there was no flow.Switch to the emergency hand pump.No flow back to the cardiohlep unit.The machine was turned off and on again.Return to normal with flow.The client thinks the problem is with the patient due to hypovolemia.The customer does not think the problem is with the hls set or the cardiohelp machine or the hls set." the patient is alive.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that after six hours of ecmo therapy the cardiohelp stopped, caused by an alarm message on the device (error message: pump disposable error).The patient had a cardiac arrest while the perfusionist was present.The pump was running again, but no flow could be achieved.The customer switched to the emergency drive and could not achieve a flow.Therefore the machine was turned off and on again.A normal flow could be achieved.The customer thinks the problem is with the patient due to hypovolemia, he does not think the problem is with the hls set or the cardiohelp.The patient was connected to the cardiohelp because of his precondition of diabetic, atheromatosis and coronary syndrome.The failure occurred during treatment and the patient is alive.A getinge service technician (fst) was sent for investigation on 2022-06-16.The fst performed safety, calibration, and functionality checks to factory specifications on the cardiohelp device.All function tests are passed.No sparepart was exchanged.According to the logfile analysis the error message "no disposable detected" and "pump disposable error - stop" occurred multiple times.These are error messages when the pump gets started without a disposable is connected or the disposable is disconnected while the pump is running.A medical review was performed by getinge medical affairs.The customers statement describes hypovolemia as the cause of the cardiac arrest.The decreased volume status results in a reduced preload.Since centrifugal pumps are preloead dependent, a too low preload can cause flow problems even though the pump is running.An increasing negative venous pressure could have been an indicator for this situation.The collapsed venous line indicates the reduced venous drainage.The fact that no flow could be generated during the use of the emergency drive also indicates that the flow problems were not due to possible malfunctions of the cardiohelp.According to the liver bleeding of the patient a hypovolemia was caused.After administering volume to the patient the flow could be achieved.The root cause for this adverse event was the hypovolemia of the patient.The result of the fst and the statement of the customer supports this assessment.The review of the non-conformities has been performed on 2022-05-17 for the period of 2017-11-01 to 2022-05-13.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.The device was manufactured on 2017-11-01.Based on the investigation results the reported failure "stop of the machine, cardiac arrest of the patient" could be confirmed, but was not related to a malfunction of the cardiohelp device.The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.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.Note: the affected hls set will be investigated within complaint# (b)(4) (mfg reporter number # 8010762-2022-00189).

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: 14433080
• MDR Text Key: 292032663
• Report Number: 8010762-2022-00178
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

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 Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 80 KG