BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 24257105 · Received February 4, 2026

    Report

    Report Number
    8010762-2026-0000045
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 27, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863078298
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 2026-02-17 THAT THE PRESSURES WERE ZEROED WHILE THE HLS SET WAS DRY AND NO VISUAL DAMAGES WERE OBSERVED ON THE HLS SET. THE CUSTOMER CONFIRMED THAT THE CARDIOHELP IS NOT THE FAULT, AS WHEN THE CARDIOHELP WAS USED ON ANOTHER HLS SET ON A LATER POINT, NO FAULT OCCURRED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

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

    COMPLAIN ID (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN GERMANY DURING PRIMING. IT WAS REPORTED THAT THE CUSTOMER FOUND A ABNORMALITY OF THE PRESSURE VALUES. THE HLS SET WAS PRIMED ACCORDING TO THE INSTRUCTION OF USE. AFTER THE PRIMING PROCEDURE WAS FINISHED, THE PRESSURE READING ISSUE OCCURRED. THE CUSTOMER TRIED TO ZERO THE PRESSURE VALUES, WITHOUT SUCCESS. NO HARM TO ANY PERSON HAS BEEN REPORTED. A PRESSURE READING ISSUE, CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553054 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000464736 04058863078298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown