MAUDE Adverse Event Report: Maquet Cardiopulmonary GmbH Cardiohelp; Console, Heart-Lung Machine, Cardiopulmonary Bypass

Model Number	Cardiohelp-i
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2026
Type of Reportable Event	Death
Event or Problem Description
The event occurred in china during treatment.It was reported that the cardiohelp package detached during transport of the patient, causing a backflow for 6 minutes.The patient passed.As the patient passed, 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 chinese 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 701048012.

• 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: 50915513
• Report Number: 8010762-2026-0000588
• Device Sequence Number: 5344860
• Product Code: DTQ
• UDI-Device Identifier: 04037691658384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/28/2026

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-i
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown