BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOHELP

    MDR report key: 19739602 · Received July 15, 2024

    Report

    Report Number
    8010762-2024-00354
    Event Type
    Death
    Date Received
    July 15, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 15, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    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 WILL SUBMITTED WHEN ADDTIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH WAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES ON 2024-07-09: 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 SYSTEM¿, MANUFACTURED BY GETINGE AND DISTRIBUTED BY, OCCURRED ON 2024-01-01. THE INFORMATION WAS PROVIDED THAT THE PATIENT HAD THE INCIDENT "MAJOR BLEEDING" AND THE CONSEQUENCE FOR THE PATIENT WAS "MASSIVE HEMOTHORAX IN A PATIENT ANTICOAGULATED BECAUSE OF VITAL SUPPORT DEVICE, CAUSES HYPOVOLEMIC AND OBSTRUCTIVE SHOCK, REQUIRES SURGICAL INTERVENTION AND PREVENTS ANTICOAGULATION DUE TO ACTIVE BLEEDING FOR SEVERAL DAYS, LEADING TO WITHDRAWAL OF ECMO. " BASED ON THE INFORMATION AVAILABLE THAT THE PATIENT WAS INJURED A REPORT IS REQUIRED. ON 2024-07-22 THE INFORMATION WAS RECEIVED THAT THE PATIENT EXPIRED. THE GETINGE SERVICE AND SALES UNIT (SSU) NOTIFIED THAT THE CUSTOMER CONFIRMED THAT NEITHER THE HLS SET NOR THE CARDIOHELP DEVICE HAD A FAILURE. BASED ON THE AVAILABLE INFORMATION THE REPORTED EVENT "MAJOR BLEEDING" COULD BE CONFIRMED, BUT WAS NOT RELATED TO A DEVICE MALFUNCTION. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE CARDIOHELP DEVICE AS A SINGLE EVENT (TIMEFRAME FROM 2023-07-09 TILL 2024-07-09) THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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. NOTE: THE SERIAL NUMBER OF THE CARDIOHELP DEVICE WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE THE UDI CANNOT BE PROVIDED. H3 OTHER TEXT: NO MALFUNCTION ON DEVICE.

    Description of Event or Problem · 0

    FOLLOWING WAS INITIALLY REPORTED: THE VIGILANCE AREA OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES HAS BEEN INFORMED THROUGH RENACER REGISTRY ABOUT AN INCIDENT REPORT NOTIFIED BY DR. (B)(6), INVOLVING THE PRODUCT ¿CARDIOHELP SYSTEM¿, MANUFACTURED BY MAQUET CARDIOPULMONARY GMBH OCCURRED ON 01/01/2024, IN THE (B)(6) HOSPITAL. INCIDENT DESCRIPTION: MAJOR BLEEDING. MASSIVE HEMOTHORAX IN A PATIENT ANTICOAGULATED BECAUSE OF VITAL SUPPORT DEVICE, CAUSES HYPOVOLEMIC AND OBSTRUCTIVE SHOCK, REQUIRES SURGICAL INTERVENTION AND PREVENTS ANTICOAGULATION DUE TO ACTIVE BLEEDING FOR SEVERAL DAYS, LEADING TO WITHDRAWAL OF ECMO. NO ADDITIONAL INFORMATION WAS RECEIVED. FURTHER INFORMATION ABOUT THE EVENT AND DEVICE WAS REQUESTED BUT IS STILL PENDING. 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
    286901 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| D