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

Model Number	CARDIOHELP-I
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred in the usa.It was reported, that the cardiohelp alarmed "venous bubble sensor defective" during treatment.The customer used another sensor and this solved the failure.The defective venous bubble sensor shows a slight fraying on the cord.The cardiohelp was not replaced.No harm to any person has been reported.Complaint id: (b)(4).
Additional Manufacturer Narrative
A follow up will submitted when additional information become available.
Event or Problem Description
Complaint id: (b)(4).
Additional Manufacturer Narrative
It was reported, that the cardiohelp alarmed "venous bubble sensor defective" during treatment.It was confirmed, that no error message was displayed.Only an audible alarm occurred.Another venous bubble sensor was used to continue treatment.The cardiohelp was not exchanged.No harm to any person has been reported.As a venous bubble sensor defective alarm is a high priority alarm, which leads to zero mode flow, a report is needed.Following patient dates were provided: female, 21 years, 71 kg, 157 lbs.A getinge technician was sent for investigation.The venous bubble sensor will be replaced.It was confirmed by the getinge technician, that the root cause was a slight frayed cable.Additionally, according to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure:- bubble sensor defectiveaccording to the instructions for use (ifu), chapters "monitoring and sensors" and "bubble monitoring: function test" the venous bubble sensor and the arterial flow/bubble sensor have to be tested before each use.The cardiohelp has a flow/bubble sensor for bubble detection.The venous bubble sensor is optional and for additional bubble detection.Referring to the ifu of the cardiohelp (chapter "cleaning and disinfection", the cables and the whole device should be cleaned after each use to remove soiling or residual blood.Furthermore in chapter "connecting the sensors", it is stated that the sensors must be kept clean.The device was manufactured on 2022-09-02.The review of the non-conformities has been performed on 2026-04-27 for the period of 2022-09-02 to 2026-03-01.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.In addition, a review for potential field actions and capas related to the failure and product in this complaint was performed.This complaint is not in scope of any ongoing field actions and/or capas.Based on the results the reported failure "venous bubble sensor defective" could be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.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.

• 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: 24495160
• Report Number: 8010762-2026-0000091
• Device Sequence Number: 5092095
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 71 KG