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	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
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 while priming the hls set, a "pump disposable error" occurred.The hls set was moved to 3 cardiohelp units and displayed the same error.Ssu confirmed on 2026-04-01 that there was no issue with the cardiohelp devices, and no visible damage was noticed on the hls set.The set was not used for treatment.No patient was involved.No harm to any person has been reported.As the ¿pump disposable error" could lead to a pump stop during treatment therefore 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: 24764147
• Report Number: 8010762-2026-0000154
• Device Sequence Number: 10268317
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)251031(17)261031(10)3000513862(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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: 3000513862
• 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: 03/30/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown