BEUDAMED
    FDA Adverse Event Death Summary report: N

    TUBING SET

    MDR report key: 24543879 · Received March 9, 2026

    Report

    Report Number
    8010762-2026-0000105
    Event Type
    Death
    Date Received
    March 9, 2026
    Date of Event
    March 3, 2026
    Report Date
    April 1, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION WAS RECEIVED ON 2026-03-26 THAT THE PATIENT WAS A 69-YEAR-OLD MALE, WITH 95KG AND A HIGHT OF 175CM. THE HLS SET WAS PRIMED AND CONNECTED TO THE PATIENT ON (B)(6) 2026. THE PRESSURES WERE ZEROED WHILE THE SET WAS EMPTY. THERE WAS NO DEFECT ON THE SENSOR HOUSING OR FLEXLINE. THE CARDIOHELP COULD BE EXCLUDED AS THE FAULT ACCORDING TO THE CUSTOMER. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026 THAT THE THERAPY WAS STOPPED DUE TO PALLIATIV REASONS OF THE PATIENT. THE THERAPY GOAL COULD NOT BE REACHED AND THE TREATMENT WAS STOPPED. IT WAS CONFIRMED BY THE CUSTOMER THAT THE PRESSURE READING ISSUE DID NOT HAD ANY IMPACT ON THE PATIENT SITUATION. THE PATIENT WAS CONNECTED TO THE ECMO DUE TO ARDS (ACUTE RESPIRATORY FAILURE). THE PATIENT PASSED AWAY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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

    COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN GERMANY DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE HLS SET WAS PRIMED AND DE-AIRED WITHOUT ANY ABNORMALITIES. ALL PRESSURES WERE ZEROED DURING PRIMING. AFTER CONNECTING TO THE PATIENT, ACCURATE PRESSURE READINGS WERE OBTAINED VIA THE PRESSURE SENSORS ON THE HLS SET AND DISPLAYED ON THE INVOLVED CARDIOHELP DEVICE. 30 MINUTES AFTER STARTING THE TREATMENT, THE PVEN MEASUREMENT FAILED. THE FIELD FOR PVEN DISPLAYED NOTHING. TO EXCLUDE ANY HARDWARE-RELATED CAUSES, THE HLS CABLE AND CARDIOHELP WERE REPLACED. IN COMBINATION WITH THE HLS SET BEING USED, PVEN WAS NOT DISPLAYED. IN COMBINATION WITH ANOTHER DEMO SET, PVEN COULD BE DISPLAYED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE HLS SET WAS REPLACED DURING PATIENT TREATMENT A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605774 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000488617 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death