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

Model Number	Cardiohelp-i
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in usa during service.It was reported that the venous bubble sensor is defective error message was displayed.No harm to any person has been reported.As a bubble sensor defective alarm could lead to a zero flow mode, a report is required.It was confirmed that there was no visible damage on the sensor and its cable.A getinge technician was sent for investigation.The venous bubble sensor was sent back to customer labelled as defective and not for use.The cardiohelp was tested and passed all functions and has no malfuntion.The affected venous bubble sensor will be replaced as part of the ongoing fsca.Another venous bubble sensor with a similar failure was already investigated by the supplier (b)(4) on 2020-04-28.Following possible root causes were determined: - damaged wiring inside the cable due to mechanical tension - damage due to overvoltage or esd (electrostatic discharge).In order to investigate further, several venous bubble sensors were returned for investigation to getinge life-cycle-engineering and investigated on 2025-12-01 within the non-conformity.The root cause was determined as a separation of conductors in the cable near the sensor.As a remedial measure, the feed opening for the conductors must be closed before casting by the supplier during manufacturing.The investigation and actions within this non conformity are ongoing.Fsca was initiated.Referring to the fsca it is stated that "internal investigations have identified an issue with the durability of the connecting cable near the connection to the bubble sensor.Excessive bending of the cable can lead to poor contact, which may trigger the errors ¿ven.Bubble sensor defective¿ or ¿ven.Bubble sensor disconnected¿ on the connected medical device (rotaflow ii or cardiohelp-i).These errors can occur temporarily when the cable is moved or permanently if the connection is fully compromised.Upon availability of the new design: a new material 701055720 "bs 3/8x3/32 l1.7" (bubble sensor for 3/8¿ x 3/32¿ tubing, length 1,7 m) will be required for each exchanged sensor." the fsca is ongoing.According 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.According 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 review of the non-conformities has been performed on 2026-09-29 for the period of beginning of ncs to 2026-09-21.In order to investigate the reported failure "venous bubble sensor malfunction/defective" further an internal nonconformity was initiated in november 2025.The investigation and actions within this non conformity are ongoing.In addition, a review for potential field actions and capas related to the failure and product in this complaint was performed.This complaint is in scope of capa and fsca was initiated.Based on the results the reported failure "venous bubble sensor defective" could be confirmed.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.
Event or Problem Description
The event occurred in usa during service.It was reported that the venous bubble sensor is defective error message was displayed.No harm to any person has been reported.As a bubble sensor defective alarm could lead to a zero flow mode, a report is required.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: 50946109
• Report Number: 8010762-2026-0000595
• Device Sequence Number: 13149651
• Product Code: DTQ
• UDI-Device Identifier: 04037691658384
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/30/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown