BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLS SET ADVANCED 7.0

    MDR report key: 19070221 · Received April 9, 2024

    Report

    Report Number
    3008355164-2024-00011
    Event Type
    Death
    Date Received
    April 9, 2024
    Date of Event
    March 16, 2024
    Report Date
    April 26, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH HAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICE ON (B)(6) 2024: 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 (B)(6) 2024. THE FOLLOWING INFORMATION WAS PROVIDED: ¿PATIENT ISCHEMIC STROKE WITH PATIENT ENCEPHALIC DEAD.¿ ON (B)(6) 2024 THE INFORMATION FROM THE CUSTOMER WAS RECEIVED THAT NEITHER THE CARDIOHELP NOR THE HLS SET HAS ANY FAILURE OR MALFUNCTION. THE HLS SET WAS DISCARDED BY THE CUSTOMER. BASED ON THE AVAILABLE INFORMATION THE REPORTED EVENT "PATIENT ISCHEMIC STROKE WITH PATIENT ENCEPHALIC DEAD" COULD BE CONFIRMED, BUT WAS NOT RELATED TO A DEVICE MALFUNCTION. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS AS A SINGLE EVENT (TIMEFRAME FROM (B)(6) 2023). 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. H3 OTHER TEXT : 4115.

    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.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    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) 2024: 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 (B)(6) 2024. THE FOLLOWING INFORMATION WAS PROVIDED: ¿PATIENT ISCHEMIC STROKE WITH PATIENT ENCEPHALIC DEAD.¿ COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607150 HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 7050 #SHLS SET ADVANCED 7.0 3000341910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death