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	11/25/2025
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
It was reported that the cardiohelp device had no issues upon initiation.Sometime later, the pump gave the "art bubble sensor defective" message.The perfusionist running the pump tried cleaning the sensor and replacing it but the alarm did not resolve.They then went to another pump they had and took the flow/bubble sensor off that pump and tried it, also without resolution of alarm.They ended up switching the hls set to another pump and resumed therapy without issue.No harm to any person has been reported.The cardiohelp was replaced during treatment and an arterial bubble sensor defective alarm is a high priority alarm, which leads to a pump stop, if intervention is set by the user, therefore a report is required.Complaint id: (b)(4).
Event or Problem Description
Complaint id (b)(4).
Additional Manufacturer Narrative
Additional information received on 2025-12-09.The hls set was transferred successfully with no harm to the patient.Further it was confirmed, that there was no failure of the hls set.A follow-up medwatch will be submitted when additional information becomes available.
Event or Problem Description
Complaint id (b)(4).
Additional Manufacturer Narrative
It was reported that the cardiohelp device had no issues upon initiation.Sometime later, the pump gave the "art bubble sensor defective" message.The perfusionist running the pump tried cleaning the sensor and replacing it but the alarm did not resolve.They then went to another pump they had and took the flow/bubble sensor off that pump and tried it, also without resolution of alarm.They ended up switching the hls set to another pump and resumed therapy without issue.No harm to any person has been reported.The cardiohelp was replaced during treatment and an arterial bubble sensor defective alarm is a high priority alarm, which leads to a pump stop, if intervention is set by the user, therefore a report is required.The patient data was not received, efforts were made on 2026-02-04 to request the missing patient data.A getinge technician was sent for investigation.The flow bubble sensor will be replaced.The technician performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and the reported failure could be confirmed on the date of event.The technician also confirmed that there was no visible damage on the sensor.Another flow/bubble sensor was investigated by life-cycle-engineering on 2023-01-13.The error message "arterial flow/bubble sensor defective" could be reproduced.For a deeper investigation the affected sensor was sent to the supplier for investigation.The root cause is a defective eeprom due to an external impact.According to the instruction for use (ifu) chapter "connecting the combined flow/bubble sensor" the bubble monitoring function test and flow off-set calibration has to be performed before every use.Thus, a defective flow/bubble sensor should be detected prior to use, during priming.In addition, as the cardiohelp includes pressure sensors and a venous probe it is able to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.In the ifu chapter "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.The device was manufactured on 2020-06-04.The review of the non-conformities has been performed on 2025-12-04 for the period of 2020-06-04 to 2025-11-25.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 " arterial flow/bubble sensor was 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.
Additional Manufacturer Narrative
It was reported that the cardiohelp device had no issues upon initiation.Sometime later, the pump gave the "art bubble sensor defective" message.The perfusionist running the pump tried cleaning the sensor and replacing it but the alarm did not resolve.They then went to another pump they had and took the flow/bubble sensor off that pump.They ended up switching the hls set to another pump and resumed therapy without issue.No harm to any person has been reported.The cardiohelp was replaced during treatment and an arterial bubble sensor defective alarm is a high priority alarm, which leads to a pump stop, if intervention is set by the user, therefore a report is required.The patient data was not received, efforts were made on 2026-02-04 to request the missing patient data.New information received on 2026-03-10 that the cradiohelp device was sent to depot for repair and the sensor panel was found as the cause of the reported failure.A getinge technician from the depot center investigated the device.The technician confirmed that there was no visible damage on the sensor.The sensor panel was replaced.The technician performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and the reported failure could be confirmed on the date of event.A similar failure was investigated by the getinge life-cycle-engineering (lce).An unreliable plug connection on the digiflow mini board led to the error.According to the instruction for use (ifu) chapter "connecting the combined flow/bubble sensor" the bubble monitoring function test and flow off-set calibration has to be performed before every use.Thus a defective flow/bubble sensor should be detected prior to use, during priming.In addition as the cardiohelp includes pressure sensors and a venous probe it is able to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.In the ifu chapter "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.The review of the non-conformities has been performed on 2026-03-11 for the period of 2020-06-04 to 2025-11-25.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.The device was manufactured on 2020-06-04.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 " arterial flow/bubble sensor was 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.
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: 23714247
• Report Number: 8010762-2025-0000539
• Device Sequence Number: 16052725
• Product Code: DTQ
• UDI-Device Identifier: 04058863074863
• UDI-Public: (01)04058863074863(11)200604
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/12/2026

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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 02/04/2026; 03/10/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/12/2025; 02/16/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown