MAUDE Adverse Event Report: Maquet Cardiopulmonary GmbH Tubing Set; Oxygenator, Cardiopulmonary Bypass

Model Number	HLS Set
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.Note: no udi number has been included in the section d4 unique device identifier (udi) since the lot number of the affected set was not provided yet.Therefore it is not possible to identify the set lot number of the device in question and therefore its udi number.
Event or Problem Description
The event occurred in the usa.It was reported that the venous pressure reading was unreliable.Further, a clicking sound was heard when the sensor cable was moved towards the hls-set connection.No harm to any person has been reported.As a pressure reading issue can lead to a pump stop, if the intervention is set by the user a report is required.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: 25067533
• Report Number: 8010762-2026-0000205
• Device Sequence Number: 10358031
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)250915(17)260915(10)3000503542(240)701069078
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/08/2026

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: 09/15/2026
• Device Model Number: HLS Set
• Device Catalogue Number: 701069078
• Device Lot Number: 3000503542
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 05/30/2026; 08/24/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/26/2026; 06/08/2026; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown