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

Model Number	CARDIOHELP
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Maquet cardiopulmonary gmbh has received the following information from the spanish agency of medicines and medical devices on 2026-01-19: the vigilance area of medical devices of the spanish agency of medicines and medical devices has been informed through renacer registry about an incident involving the product ¿cardiohelp¿, manufactured by getinge and distributed by, occurred on (b)(6) 2025 with report number (b)(4).The information was provided that the patient had the incident "neurological event.Left anterior circumflex artery ischaemic stroke".As the patient suffered a serious injury, a report is required.Complaint id# (b)(4).
Additional Manufacturer Narrative
A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.Note: this event occurred on the spanish market.It is a significantly similar device to "base unit, cardiohelp¿ which is sold in the usa under premarket submission number k133598.For section d4 all available identifying information is for the out of the us device, subjected to this report.Therefore, no gudid information exists.Furthermore, udi information (primary di number) provided in d4 is for cardiohelp with catalog number 701047999.
Additional Manufacturer Narrative
Maquet cardiopulmonary gmbh has received the following information from the spanish agency of medicines and medical devices on (b)(6) 2026: the vigilance area of medical devices of the spanish agency of medicines and medical devices has been informed through renacer registry about an incident involving the product ¿cardiohelp¿, manufactured by getinge and distributed by, occurred on (b)(6) 2026.The information was provided that the patient had the incident "neurological event.Left anterior circumflex artery ischaemic stroke".As the patient suffered a serious injury, a report is required.New information was received on (b)(6) 2026 were the customer confirmed that no getinge device/product which was used presented any fault, as well as that the patients outcome is not due to any getinge product.Further it was confirmed that the getinge disposables, which were used, are discarded.Additionally, it was confirmed that the cardiohelp was reviewed and no fault was found.The cardiohelp was used on other patients without identifying failures.Following patient data was shared: male, 45 years old with 83kg and a height of 178cm.No device history review, no review of scrap, rework, enhancements and design changes was performed, as no failure of the device was reported.In addition, no review for potential field actions and capas related to the event and product in this complaint and no review of the non-conformities has been performed, as this complaint was reported due to the event and not due to a failure on a getinge product.Based on the available information the reported event could not be linked to a device defect/failure.Therefore, the complaint could not be confirmed.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 or Problem Description
Complaint id (b)(4).

• Brand Name: CARDIOHELP
• Common Device Name: 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: 24158722
• Report Number: 8010762-2026-0000028
• Device Sequence Number: 21082888
• Product Code: DTQ
• UDI-Device Identifier: 04037691658247
• UDI-Public: (01)04037691658247
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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
• Operator of Device: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 701047999
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 83 KG