BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING SET

    MDR report key: 24143280 · Received January 22, 2026

    Report

    Report Number
    8010762-2026-0000027
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    September 1, 2025
    Report Date
    February 26, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 SPANISH 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 ST WITH CATALOG NUMBER 701069073.

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH HAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES ON (B)(6) 2026: THE VIGILANCE AREA OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES HAS BEEN INFORMED THROUGH RENACER REGISTRY ABOUT AN INCIDENT INVOLVING THE PRODUCT ¿CARDIOHELP¿, MANUFACTURED BY GETINGE AND DISTRIBUTED BY, OCCURRED ON (B)(6) 2025. THE INFORMATION WAS PROVIDED THAT THE PATIENT HAD THE INCIDENT "MAJOR BLEEDING: MEDIASTINAL HAEMORRHAGE WITH CARDIAC TAMPONADE". NEW INFORMATION WAS RECEIVED ON 2026-02-06 FROM THE CUSTOMER THAT THE PATIENT EXPERIENCED DURING ECMO SUPPORT A COMPLICATION OF A SUSPECTED CARDIAC TAMPONADE AND LEFT HEMOTHORAX. THE PATIENT UNDERWENT A SURGICAL REVISION, AFTER WHICH THE EVENT WAS RESOLVED. THE CUSTOMER CONFIRMED THAT THERE WAS NO FAILURE OF A GETINGE DEVICE USED. THE FOLLOWING PATIENT DATA WAS SHARED: 47-YEAR-OLD MALE WITH 97KG. NO DEVICE HISTORY REVIEW, NO REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WAS PERFORMED, AS NO FAILURE OF THE DEVICE WAS REPORTED. IN ADDITION, NO REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE EVENT AND PRODUCT IN THIS COMPLAINT AND NO REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED, AS THIS COMPLAINT WAS REPORTED DUE TO THE EVENT AND NOT DUE TO A FAILURE ON A GETINGE PRODUCT. BASED ON THE AVAILABLE INFORMATION THE REPORTED EVENT COULD NOT BE LINKED TO A DEVICE DEFECT OR FAILURE. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    MAQUET CARDIOPULMONARY GMBH HAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES ON 2026-01-19: THE VIGILANCE AREA OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES HAS BEEN INFORMED THROUGH RENACER REGISTRY ABOUT AN INCIDENT INVOLVING THE PRODUCT ¿CARDIOHELP¿, MANUFACTURED BY GETINGE AND DISTRIBUTED BY, OCCURRED ON (B)(6) 2025 WITH REPORT NUMBER (B)(4). THE INFORMATION WAS PROVIDED THAT THE PATIENT HAD THE INCIDENT "MAJOR BLEEDING: MEDIASTINAL HAEMORRHAGE WITH CARDIAC TAMPONADE". AS THE PATIENT SUFFERED A SERIOUS INJURY, 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
    364710 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000459825 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Life Threatening| O