BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET

    MDR report key: 24636274 · Received March 19, 2026

    Report

    Report Number
    8010762-2026-0000132
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    March 12, 2026
    Report Date
    March 19, 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
    EZ
    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 CZECHIA 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 CZECHIA. IT WAS REPORTED THAT A HIGH DELTA P IN THE HLS SET WAS NOTICED. THE PRESSURE INCREASED DURING THE FIRST 20 MINUTES AFTER STARTING ECMO THERAPY ON CARDIOHELP. THERAPY WITH THE AFFECTED HLS SET WAS TERMINATED AND THE ENTIRE HLS SET WAS REPLACED WITH A NEW HLS SET. NO PROBLEM WITH THE NEW HLS SET WAS NOTICED AND THERAPY COULD CONTINUE. NO HARM TO ANY PERSON HAS BEEN REPORTED. ON (B)(6) 2026 THE SSU (SALES AND SERVICE UNIT) PROVIDE THE NEW INFORMATION AS FOLLOWS: NO CLOTS HAS BEEN NOTED IN THE HLS MODULE. HEPARIN WAS USED AS ANTICOAGULATION. NO PERFUSION PROTOCOL IS AVAILABLE. AT THE BEGINING OF ECMO THERAPY THE ANTICOAGULATION WAS USED ON THE PATIENT. DELTA PRESSURE WAS 150 AND STILL INCREASED. AFTER THE EXCHANGE OF THE HLS SET EVERYTHING WAS FINE. SINCE THERE WAS A PRESSURE ISSUE AND DUE TO EXCHANGE OF THE HLS SET DURING PATIENT TREATMENT A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704470 HLS SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 7050 #SHLS SET ADVANCED 7.0 3000513859 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention