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

Model Number	BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.
Event or Problem Description
The event occurred in the us.It was reported that a patient was picked up a patient at (b)(6).The patient was switched onto their cardio help and hls set.The hls set lasted for 48 hours with no problems ¿ than the customer noticed a crack in the disposable where blood was coming out.No harm to any person has been reported.On 2025-03-05 new information has been provided by the ssu (sales and service unit) as follows: approximately 10 ml blood was loss from circuit and no blood transfusion was required due to leakage.The hls set was connected to the patient on 2026-02-28 and the leak was noticed on 2026-03-02 on the pump housing.The hls set was replaced with a new one on 2026-03-02.Due to the reported blood leakage and the exchange of the hls set a report is required.Complaint id: (b)(4).

• Brand Name: HLS 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: 24557349
• Report Number: 8010762-2026-0000112
• Device Sequence Number: 15851406
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)251017(17)261017(10)3000510759(240)701069078
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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 Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000510759
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 69 KG