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	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
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.Initially, it was reported that a patient initiated on cardiohelp, the alarm ¿part sensor disconnected¿ occurred.Customer decided to swap the hls set to another cardiohelp using same hls set, then no tart reading and no audible alarm.Tart started working later on.No harm to any person has been reported.New information has been provided by the ssu (sales and service unit) dates on 2026-03-30 that there was an error/correction in original description of event.The tart was not reading.Part was working.On 2026-04-03 the ssu has been provided new information as follows: according to the customer it is unknown were the pressures zeroed while the set was free of liquids/priming solution.As another team primes and zeros the equipment prior to it arriving in the unit.But the system was zeroed with dry oxy after initial errors arrived.Patient was supported via hand crank during this reset.No visible defect on the sensor housing or green flexline were noticed by the staff during investigation.When was the set was primed (date) is unknown at this time.The set was connected to the patient and the failure was noticed on 2026-03-16.The hls set was not exchanged.During decannulation the hls set was discarded and is no longer available for investigation.Due to provided information that the hand crank was used during reset 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: 24843486
• Report Number: 8010762-2026-0000167
• Device Sequence Number: 9047176
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)250509(17)260509(10)3000477011(240)701069078
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 05/19/2026

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: 05/09/2026
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000477011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Weight: 53 KG