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

Model Number	HLS SET
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
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.It was reported that the patient was placed on the hls set on (b)(6) 2026.On the same day the patient was transported to the (b)(6) hospital from the (b)(6).On (b)(6) 2026 a leakage on the hls set was noticed.The leakage was located at the luer lock site on the pre-membrane side of the hls module.The customer stated that there was a pigtail connected to the luer lock, which was there when the patient had been transferred in.Further, a crack was noticed on the hls module at the connection site.Thus, the affected hls set was replaced.In addition, the patient received a blood transfusion.The amount of blood loss is unknown.The customer confirmed that there was no complication for the patient.Complaint id# (b)(4).
Event or Problem Description
Complaint id# (b)(4).
Additional Manufacturer Narrative
New information was received on 2026-03-19.The customer stated, that the patients indication for the treatment was a cardiogenic shock.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: 24516703
• Report Number: 8010762-2026-0000096
• Device Sequence Number: 9746239
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)250715(17)260715(10)3000492279(240)701069078
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2026
• Device Model Number: HLS SET
• Device Catalogue Number: 701069078
• Device Lot Number: 3000492279
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 06/10/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/08/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 56 KG