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 Codes	Environmental Particulates (2930); Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred in the us.It was reported that while priming a hls set a "foreign body" described as something that looked like a short hair was observed in the hls module.The device was then removed from the cardiohelp unit and never used on a patient.The hls set was saved, however the clinician drained the device for saving and, when doing that, the strand disappeared.No harm to any person has been reported.If a foreign object is not detected prior to use, it may enter the blood circulation during clinical use, which could be a risk to the patient; therefore, a report is required.Complaint id: (b)(4).
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.

• 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: 50295731
• Report Number: 8010762-2026-0000474
• Device Sequence Number: 10733158
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)260203(17)270203(10)3000533570(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): 08/14/2026

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 Model Number: BEQ-HLS 7050 USA #SHLS Set Advanced 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000533570
• 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: 08/11/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown