MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	HLS SET
Medical Device Problem Code	Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred in the usa prior to use.It was reported that a foreign object, a cloudy white particle, was seen in the priming bag of the hls set.The affected hls set was primed on (b)(6) 2026.The priming bag was stored on sprinter cart iv pole.The priming solution is stored in cabinet in icu.The circuit was primed with plasma-lyte a injection ph 7.4 with two 1-liter bags.A portion of the plasmalyte was still in the second bag attached to the circuit.On (b)(6) 2026 the cloudy object was noticed within the priming bag.It was confirmed, that there were not any environmental conditions present at the time which could have influenced the event.The affected product was not used on a patient.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
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: 25575886
• Report Number: 8010762-2026-0000315
• Device Sequence Number: 13032409
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383(11)260109(17)270109(10)3000526211(240)701069078
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/22/2026

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: HLS SET
• Device Catalogue Number: 701069078
• Device Lot Number: 3000526211
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown