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

Model Number	Cardiohelp-i
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction

• 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: 50218389
• Report Number: 8010762-2026-0000463
• Device Sequence Number: 16038797
• Product Code: DTQ
• UDI-Device Identifier: 04037691658384
• UDI-Public: (01)04037691658384(11)161118
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Cardiohelp-i
• Device Catalogue Number: 701048012
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 11/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown