BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 24480678 · Received March 2, 2026

    Report

    Report Number
    8010762-2026-0000089
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 23, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 (B)(6) 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 HONG KONG DURING TREATMENT. IT WAS REPORTED THAT THERE WAS A SOUND COMING FROM THE CARDIOHELP OR DISPOSABLE WHEN THE RPM WAS INCREASED. THE GETINGE TECHNICIAN COULD NOT CONFIRM A SPECIAL SOUND COMING FROM THE CARDIOHELP OR HLS SET USED. FOLLOWING PATIENT DATA WAS SHARED: 46-YEAR-OLD MALE WITH 80KG. FURTHER THERE WAS AN ISSUE WITH THE FLOW NOT WORKING. EVEN WHEN THE RPM WAS INCREASED THE FLOW WAS NOT WORKING. THE HLS SET AND CARDIOHELP DEVICE WERE REPLACED DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE HLS SET WAS SEATED CORRECTLY AND RE-SEATING WAS TRIED. THERE WAS NO VISUAL DAMAGE ON THE HLS SET. THE HLS SET WAS PRIMED ON (B)(6) 2026. THE NOISE OCCURRED, ACCORDING TO THE CUSTOMER, WHEN THE HLS SET WAS CONNECTED TO THE PATIENT AND WHEN THE SET WAS DISCONNECTED FROM THE MACHINE AND MOVED TO THE EMERGENCY DRIVE. THE CARDIOHELP WILL BE INVESTIGATED IN COMPLAINT# (B)(4). AS THERE WAS NO FLOW GENERATION POSSIBLE DURING TREATMENT AND THE HLS SET WAS REPLACED, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340768 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000499362 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male