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); Pressure Problem (3012)
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 treatment.It was reported that the cardiohelp part sensor went from normal readings to -491 mmhg.Account changed consoles and the problem resolved.Pump was in use for 150 hours on this patient.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 2026-02-23.No pump stop occurred.Further it was confirmed, that there was no failure of the hls set and no visible damage on the hls cable and the sensor panel.The cardiohelp was changed and the problem was resolved.A follow-up medwatch will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Additional information received on 2026-03-09.The getinge technician corrected the serial number.A follow-up medwatch will be submitted when additional information becomes available.
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: 24374284
• Report Number: 8010762-2026-0000068
• Device Sequence Number: 14662014
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/08/2026

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
• 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: 02/23/2026; 03/09/2026; 04/30/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 02/26/2026; 03/19/2026; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 25 MO
• Patient Sex: Female
• Patient Weight: 11 KG