BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 24870961 · Received April 14, 2026

    Report

    Report Number
    8010762-2026-0000176
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 14, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    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: 701069073.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT DURING PRIMING PROCEDURE ON (B)(6) 2026. THE HLS SET WAS LEAKING. THE LEAKAGE WAS LOCATED AT THE POST-OXY-OUTFLOW (CONNECTION BETWEEN THE CONNECTOR AND THE TUBE). THE AFFECTED HLS SET WAS NOT USED FOR PATIENT TREATMENT; ANOTHER HLS SET WAS USED FOR THE PLANNED PATIENT TREATMENT. THE GETINGE SALES AND SERVICE UNIT CONFIRMED THAT THERE WAS NO DELAY IN TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. A LEAKAGE DURING/ AFTER PRIMING CAN LEAD TO A DELAY IN TREATMENT AND CAN ALSO OCCUR DURING TREATMENT, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80755 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000501916 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown