MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	HLS SET
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred in the usa.It was reported that during patient treatment involving an hls set and a cardiohelp device, the error message "no disposable detected" was displayed.The perfusionist reseated the hls set correctly, however the alarm remained.The patient was placed on support on (b)(6) 2026 in the evening at an outside hospital when the alarm occurred.The patient then was transported to a facility and the cardiohelp used for transport read this alarm as well.When the patient arrived at the facility and the hls set was moved to the current cardiohelp, the alarm was still present and not cleared with reseating the hls set in the cardiohelp.It was confirmed that all the readings regarding pressures, flow, rpm were accurate.No harm to any person has been reported.As the reported failure can lead to a pump stop, if the intervention is set by the user a report is required.Complaint id# (b)(4).
Additional Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The following new information has been received on (b)(6) 2026 : the customer confirmed, that no additional patient data (patient height and initials) were available.No other medical devices were used in conjunction with the event.The patients pre-existing medical conditions and indication for ecmo were the following: cad, as.No harm to any person has been reported.No pre-medical conditions or environmental conditions present at the time, which could influence the event.The affected hls set was primed on (b)(6) 2026 and connected on the same day to the patient.The reported "no disposable detected" alarm occurred on the initial used cardiohelp device, the cardiohelp device which was used during transport and the third cardiohelp device where the patient was transferred after transport.No replacement of the affected hls set was performed.The cardiohelp was excluded as fault.A follow-up medwatch will be submitted when additional information becomes available.
Event or Problem Description
Complaint id# (b)(4).

• Brand Name: TUBING SET
• Common Device Name: OXYGENATOR, 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: 25427579
• Report Number: 8010762-2026-0000281
• Device Sequence Number: 10322055
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)250902(17)260902(10)3000500774(240)701069078
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112360
• 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
• Report Date (Section B): 06/23/2026

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 Expiration Date: 09/02/2026
• Device Model Number: HLS SET
• Device Catalogue Number: 701069078
• Device Lot Number: 3000500774
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 76 KG