BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 24275615 · Received February 6, 2026

    Report

    Report Number
    8010762-2026-0000055
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 23, 2026
    Report Date
    May 8, 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

    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 701069076.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN GERMANY DURING PRIMING. IT WAS REPORTED THAT THE ARTERIAL PRESSURE (P-ART) WAS NOT DISPLAYED AND COULD NOT BE ZEROED. THE HLS SET WAS NEVER ON A PATIENT AS IT WAS ONLY PREPRIMED. THE GETINGE SERVICE AND SALES UNIT TESTED THE CARDIOHELP ON THEIR TEST HLS SET, WITH THE SAME RESULT. THE PRESSURE CONNECTOR WAS REPLACED, BUT THIS DID NOT RESOLVE THE READING ISSUE. THEREFORE, A GETINGE TECHNICIAN WENT ON SITE TO TEST THE CARDIOHELP DEVICE. NO ISSUE WAS FOUND BY THE GETINGE TECHNICIAN WHILE TESTING THE CARDIOHELP DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. NEW INFORMATION WAS RECEIVED ON 2026-01-29 THAT WHILE THE SET WAS EMPTY THE PRESSURES WERE ZEROED BY THE CUSTOMER. THE AFFECTED HLS SET WAS PRIMED BY THE ON THE SAME DATE THE EVENT OCCURRED WHICH WAS ON 2026-01-23. A GETINGE TECHNICIAN WAS SENT FOR INVESTIGATION, NO. PART WAS REPLACED. FST WAS ABLE TO CONFIRM THAT THERE WAS NO FAULT ON THE CARDIOHELP DEVICE. THE TECHNICIAN PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. 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
    94906 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 3000482352 04058863078298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown