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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
Event or Problem Description
The event occurred in the usa during patient treatment.The patient¿s treatment started at 11:30 am without any issues regarding the involved hls-set and cardiohelp device.Four hours later at 03:30 pm all readings from the integrated pressure sensor cable (arterial pressure, venous pressure, internal pressure, delta p, and arterial temperature) stopped reading on the screen and were displayed as dashes.The getinge sales and service unit (ssu) advised the customer to inspect the integrated pressure sensor cable insertion points for corrosion and the hls set integrated pressure sensor port for bent pins and fluid damage.No abnormalities were noticed.The ssu advised the customer to replace the integrated pressure sensor cable with another one from a different cardiohelp, however the issue could not be resolved.Thus, the customer decided to switch the hls set from the current cardiohelp (serial #(b)(6)) device to a new cardiohelp device (serial #90415165).However, the issues could not be resolved.The readings from the integrated pressure sensor cable were still displayed as dashes.The customer confirmed that the patient is stable and decided to continue the patient¿s treatment on the current hls set and cardiohelp device despite not having integrated pressure sensor cable readings.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 and a device replacement took place during the patient¿s treatment 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: 24275588
• Report Number: 8010762-2026-0000053
• Device Sequence Number: 8318331
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)250708(17)260708(10)3000490759(240)701069078
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/06/2026

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: 07/08/2026
• Device Model Number: HLS SET
• Device Catalogue Number: 701069078
• Device Lot Number: 3000490759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 80 KG