BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING SET

    MDR report key: 22794565 · Received August 13, 2025

    Report

    Report Number
    3013876692-2025-00067
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    August 5, 2025
    Report Date
    January 9, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    EZ
    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. 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.

    Additional Manufacturer Narrative · 0

    INFORMATION WAS RECEIVED THAT THE PATIENT HAD A MYOCARDIAL INFARCTION AND RECEIVED CARDIOPULMONARY RESUSCITATION BEFORE THE HLS-SET WAS CONNECTED AND THE INCIDENT WITH THE HLS SET DID NOT HAVE ANY IMPACT ON THE PATIENT. THEREFORE, THE TYPE OF REPORTABLE EVENT WAS CHANGED TO MALFUNCTION. THIS MDR IS BEING SUBMITTED AS A CORRECTION TO THE EVENT TYPE, AS SUCH, NO FURTHER IMPORTER MDR FOLLOW-UP IS NECESSARY.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN CZECHIA. IT WAS REPORTED THAT DURING PATIENT TREATMENT A CLICKING NOISE WAS COMING FROM THE HLS SET OXYGENATOR. THE SOUND OF THE CLICKING RESPONDED TO THE SPEED, WHEN THE SPEED WAS INCREASED, THE CLICKING BECAME LOUDER. THE HLS SET WAS PLACED ON ANOTHER CARDIOHELP DEVICE, BUT THE NOISE PERSISTED. A REPLACEMENT WAS CARRIED OUT WITH A DEVICE FROM XENIOS FRESENIUS. THE PATIENT HAD A HEART ATTACK, AFTER RESUSCITATION. AS THE PATIENT HAD TO BE RESUSCITATED AND SUFFERED A HEART ATTACK, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763921 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000451267 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| L UNKNOWN.