BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET

    MDR report key: 25013432 · Received April 28, 2026

    Report

    Report Number
    8010762-2026-0000195
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 28, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. NOTE: THIS EVENT OCCURRED ON THE CHINESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR HLS SET WITH CATALOG NUMBER 701069073.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT ON (B)(6) 2026 A BLOOD LEAKAGE AT THE ARTERIAL LUER LOCK OF THE SAMPLING LINE OF THE BE-HLS 7050 SET WAS NOTICED. THE CUSTOMER IMMEDIATELY REPLACED THE HLS SET WITH A NEW ONE. THE SET WAS PRIMED AND CONNECTED TO THE PATIENT ON (B)(6) 2026. NO LEAKAGE WAS NOTICED DURING THE PRIMING PROCESS. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED BLOOD LEAKAGE DURING PATIENT USE AND THE EXCHANGE OF THE HLS SET A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552777 HLS SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 7050 #SHLS SET ADVANCED 7.0 3000507655 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1