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	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The event occurred in the us.It was reported that on (b)(6) 2026 the customer cannulated a patient for va.Customer were flowing a little over 3l approximately 10 minutes after initiation and the delta pressure was 26 then 5-10 minutes later it shot up to the 70 in the hls set.Immediately the customer grabbed another cardiohelp to prepare it for a circuit change.By the time customer switched to the other hls set, as the delta was in the 170s.After changing the circuit, we had no issues with the flow or the deltas.No harm to any person has been reported.On (b)(6) 2026, the ssu provided additional information regarding the reported event.An iabp and an impella device were also in use during the procedure.No harm to the patient or operator was reported.The patient was experiencing cardiogenic shock and was receiving multiple vasopressors.The patient was cannulated for va ecmo support and was being transferred to a vad/transplant center for further evaluation.No pre-existing medical conditions were identified that could have influenced the reported event.No clots were observed.All pressures were zeroed while the set was free of liquids/priming solution.No visible defects were noted on the sensor housing or the green flexline.The hls set was primed on (b)(6) 2026 and connected to the patient on (b)(6) 2026.The reported malfunction was first noticed approximately 15 to 20 minutes after the set had been connected to the patient.The involved cardiohelp system had been used recently without any reported incidents.The hls set was subsequently exchanged.Due to the reported exchange of the hls set during patient use 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: 50406727
• Report Number: 8010762-2026-0000493
• Device Sequence Number: 18764372
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)260319(17)270319(10)3000546258(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): 08/24/2026

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: 3000546258
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2026
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 167 LB