MAUDE Adverse Event Report: Maquet Cardiopulmonary GmbH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	HLS SET
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred in usa during treatment.It was reported that a hls set was initiated on the patient via veno venous cannulation via right internal jugular vein with 32fr crescent dual lumen cannula.The customer stated when they advanced the rpms on the pump to increase the flow above 4 liter per minute of flow that a rattling noise was noticed.The hls set was changed to another cardiohelp, but the noise still persisted.The customer decided to replace the hls set.After replacement the noise was no longer present.The patient tolerated the circuit replacement well.The patient is a 37-year-old male with 183cm and 138kg.The circuit was initiated at 15:24 on (b)(6) 2026 and the noise started at 18:35 o clock.The hls set replacement was at 20:00.No harm to any person has been reported.As the hls set was replaced during treatment 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
New information was received on 2026-03-31 that according to the customer the set was seated correctly and reseating of the module was tried.There was no visible damage.The hls set was primed on the same date when connected to the patient.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: 24626024
• Report Number: 8010762-2026-0000128
• Device Sequence Number: 12933884
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)250908(17)260908(10)3000501921(240)701069078
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 08/26/2026

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: 09/08/2026
• Device Model Number: HLS SET
• Device Catalogue Number: 701069078
• Device Lot Number: 3000501921
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 03/31/2026; 06/04/2026; 08/25/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/16/2026; 06/23/2026; 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 303 LB