BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLS CANNULA + PIK

    MDR report key: 24869524 · Received April 14, 2026

    Report

    Report Number
    8010762-2026-0000173
    Event Type
    Death
    Date Received
    April 14, 2026
    Date of Event
    February 28, 2026
    Report Date
    May 16, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    UDI-DI
    04037691589657
    PMA / PMN Number
    K102532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Additional Manufacturer Narrative · 0

    A NEW INFORMATION RECEIVED THAT STATES THE PATIENT HAS PASSED AWAY DUE TO ILLNESS ON (B)(6) 2026, WHICH IS ONE MONTH AFTER THE FAILURE OCCURRED AND REPORTED. USER STATES THAT THIS DEATH IS NOT RELATED WITH THE REPORTED FAILURE. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ECMO TREATMENT IN THE EMERGENCY DEPARTMENT DUE TO "CARDIAC ARREST". WHEN CONNECTING THE LOOP AFTER THE ARTERIAL TUBE WAS PLACED, IT WAS FOUND THAT THE ARTERIAL TUBE WAS LEAKING BLOOD. THE TUBE WAS RE-PLACED AND THEN USED NORMALLY. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE FAILURE WAS DETECTED DURING TREATMENT, AND AN A BLOOD LEAKAGE WAS REPORTED THAT COULD CAUSE HAZARDOUS SITUATION BLOOD LOSS, THE COMPLAINT IS REPORTABLE. COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    COMPLAINT #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602168 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PAL 1723 3000441812 04037691589657

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other| D