MAUDE Adverse Event Report: Maquet Cardiopulmonary GmbH Tubing Set; Oxygenator, Cardiopulmonary Bypass

Model Number	HLS Set
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The event occurred in the us during patient treatment.It was reported that oxygenation issues with an hls set occurred during va ecmo of a 37-year-old male patient who experienced acute decompensation following transport to the operating room.While using the hls set, the hls tubing and blood observed pre- and post-oxygenator appeared dark blue despite sweep gas settings of 1 l/min at 100% oxygen.The clinical team noted that the patient may have been developing north-south syndrome.Additionally, the patient was reportedly transported without a transport ventilator and was manually ventilated by the anesthesia team using a resuscitation bag.The exact ventilation rate during transport was unknown.The ecmo manager indicated that inadequate ventilation during transport may have contributed to deoxygenation of the patient's upper body, particularly as the patient's cardiac output had increased prior to transport.The involved doctor suspected the hls set to be defective, the initial used hls set was subsequently replaced for a second hls set.Following the hls set exchange, the patient's oxygenation improved immediately.As the patient suffered a low oxygenation and the hls set was replaced during treatment, a report is required.Complaint id# (b)(4).
Additional Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.

• Brand Name: Tubing 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: 50450732
• Report Number: 8010762-2026-0000509
• Device Sequence Number: 16069674
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)260227(17)270227(10)3000540213(240)701069078
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: HLS Set
• Device Catalogue Number: 701069078
• Device Lot Number: 3000540213
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 08/31/2026; 09/30/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/01/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2026
• 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; Life Threatening
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 204 LB