BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 23252805 · Received October 9, 2025

    Report

    Report Number
    8010762-2025-0000450
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 29, 2025
    Report Date
    May 11, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE ITALIAN 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 701069065.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT CLOTTING OF THE HLS SET WAS DISCOVERED AFTER STARTING THE PATIENT'S TREATMENT. THE HLS SET WAS REPLACED, AND THE TREATMENT WAS CONTINUED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE HLS SET WAS REPLACED DURING THE PATIENT¿S TREATMENT, THE EVENT CAN RESULT IN A RISK FOR HARM OF ANY PERSON A REPORT IS REQUIRED. COMPLAINT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348289 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000484934 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male