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	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred in the usa prior to use on (b)(6) 2026.It was reported that the hls set had pressure reading issues after set-up.P ven could not be read, it was displayed as dashes.The affected hls set was primed on (b)(6) 2026.The pressures zeroed while the set was free of liquids/priming solution.No visible damage was seen on the sensor housing or green flexline.In order to rectify the issue, the hls cable was replaced.The affected hls set was as well connected to a different cardiohelp device.However, the issue could not be solved.The cardiohelp devices could be excluded as fault.The affected hls set was not connected to a patient.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).
Additional Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.

• 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: 25467577
• Report Number: 8010762-2026-0000290
• Device Sequence Number: 10306899
• Product Code: DTZ
• UDI-Device Identifier: 04058863076355
• UDI-Public: (01)04058863076355(11)250820(17)260820(10)3000498492(240)701069077
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 06/11/2026

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: 08/20/2026
• Device Model Number: HLS SET
• Device Catalogue Number: 701069077
• Device Lot Number: 3000498492
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown