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

Model Number CARDIOHELP-I

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 08/05/2022

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

Following was initially reported: ¿ incident description: ¿major bleeding.Pericannula¿.Consequences for the patient: ¿death¿.¿ complaint id# (b)(4).

Manufacturer Narrative

It was reported that the patient had a major bleeding, "pericannula" and expired during treatment.Afterwards the information was received that the patient underwent a high-risk cardiac surgery.After coming off the pump and during resuscitation the patient evolves to a deep cardiogenic shock with a big instability.After leaving the operation room the patient had central bleeding and bleeding at the cannulation points.The patient died in shock refractory to circulatory and vasoactive support as a consequence due to hemorrhage, shock and multiorgan failure.It was confirmed that this event was not related to getinge products, it was related to the complications of the process.A medical review was performed by getinge medical affairs on 2023-01-05 with following conclusion: "based on the described event, it can be determined that the patient's expiration is not likely associated with the ecmo device (i.E.Cardiohelp) or the disposables (i.E.Hls set and/or cannulae).As explained by the customer, the patient suffered cardiogenic shock after high-risk cardiac surgery and had to be resuscitated.Due to circulatory instability, the patient was connected to an ecmo, but his condition deteriorated and severe central bleeding as well as bleeding at the cannulation sites occurred.Further, it was stated by the physician that the expiration of the patient was not related to any product or device but to the severe disease and the high-risk operation.In general, surgery on ¿hot¿ endocarditis is always high-risk.The surgery exposes the already inflamed body to further potential for inflammation.The consequences are almost invariably septic shock with cardiac implications and coagulopathy with disseminated intravascular coagulopathy.The mortality is extremely high." the investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id# (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

It was reported that the patient had a major bleeding, "pericannula" and expired during treatment.Afterwards the information was received that the patient underwent a high-risk cardiac surgery.After coming off the pump and during resuscitation the patient evolves to a deep cardiogenic shock with a big instability.After leaving the operation room the patient had central bleeding and bleeding at the cannulation points.The patient died in shock refractory to circulatory and vasoactive support as a consequence due to hemorrhage, shock and multiorgan failure.It was confirmed by the customer that this event was not related to the getinge products, it was related to the complications of the process.The products cardiohelp, hls set and hls cannula were used for the treatment.There is no information from the customer about the article number or serial number of the affected products.The hls set and the hls cannulas are not available for investigation.The getinge field service technician (fst) stated that there will be no investigation of the cardiohelp device, as no failure due to the device occurred.A medical review was performed by getinge medical affairs on (b)(6) 2023 with following conclusion: "based on the described event, it can be determined that the patient's expiration is not likely associated with the ecmo device (i.E.Cardiohelp) or the disposables (i.E.Hls set and/or cannulae).As explained by the customer, the patient suffered cardiogenic shock after high-risk cardiac surgery and had to be resuscitated.Due to circulatory instability, the patient was connected to an ecmo, but his condition deteriorated and severe central bleeding as well as bleeding at the cannulation sites occurred.Further, it was stated by the physician that the expiration of the patient was not related to any product or device but to the severe disease and the high-risk operation.In general, surgery on ¿hot¿ endocarditis is always high-risk.The surgery exposes the already inflamed body to further potential for inflammation.The consequences are almost invariably septic shock with cardiac implications and coagulopathy with disseminated intravascular coagulopathy.The mortality is extremely high." based on the results the reported failure "bleeding pericannula" could be confirmed, but was not related to a device malfunction.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.H3 other text : no malfunction of the cardiohelp.

• 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: 15895695
• MDR Text Key: 304624363
• Report Number: 3008355164-2022-00032
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2023

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: CARDIOHELP-I
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2023
• Distributor Facility Aware Date: 01/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 01/05/2023; 01/19/2023
• Supplement Dates FDA Received: 01/10/2023; 01/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death