BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLS CANNULA + PIK

    MDR report key: 24108684 · Received January 19, 2026

    Report

    Report Number
    3013876692-2026-00005
    Event Type
    Injury
    Date Received
    January 19, 2026
    Date of Event
    June 25, 2024
    Report Date
    May 22, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED. THEREFORE IT IS NOT POSSIBLE TO IDENTIFY THE SET LOT NUMBER OF THE DEVICE IN QUESTION AND THEREFORE ITS UDI NUMBER.

    Description of Event or Problem · 0

    MAQUET CARDIOPULMONARY GMBH HAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICE 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 INVOLVING THE PRODUCT ¿CARDIOHELP SYSTEM¿, MANUFACTURED BY MAQUET CARDIOPULMONARY GMBH, OCCURRED ON (B)(6) 2024 IN HOSPITAL (B)(6). THE INFORMATION PROVIDED IS THE FOLLOWING: ¿THROMBUS ADHERED TO RIGHT ATRIAL CANNULA.¿ CONSEQUENCES FOR THE PATIENT: NEED FOR MEDICAL INTERVENTION TO PREVENT INJURIES OR PERMANENT DISABILITY. MEASURES: INCREASE IN COAGULATION RANGE. BASED ON THE INFORMATION AVAILABLE THAT A SERIOUS INJURY WAS REPORTED A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621054 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1