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

Model Number	CARDIOHELP-I
Medical Device Problem Codes	Device Sensing Problem (2917); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.
Event or Problem Description
The event occurred in usa during patient treatment.Customer called stating when patient went on support flow was not reading on the machine, only rpm's.Flow/bubble sensor was inspected for damage, and none was found.Cardiohelp unit was switched, and flow displayed on the screen of the new cardiohelp.Customer also noted that both cardiohelps are due for inspection.No harm to any person has been reported.The cardiohelp was replaced during treatment, therefore a report is required.Complaint id (b)(4).
Event or Problem Description
Complaint id (b)(4).
Additional Manufacturer Narrative
Additional information received on 2026-02-13, that the e-drive was not used and no pump stop occurred.The customer does not run the cardiohelp with the arterial bubble intervention turned on.Further it was confirmed that there was no visible damage on the sensor panel.A follow-up medwatch will be submitted when additional information becomes available.
Event or Problem Description
Complaint id (b)(4).
Additional Manufacturer Narrative
Additional information received on 2026-03-23.A getinge technician was sent for investigation and found a defective bubble sensor.A new one was ordered and replaced.Unit works fine at this time.The investigation is ongoing.A follow-up medwatch will be submitted when additional information becomes available.

• 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: 24362235
• Report Number: 8010762-2026-0000066
• Device Sequence Number: 20042861
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2026

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: 701072780
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 02/13/2026; 03/23/2026; 04/28/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/30/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 56 KG