BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOHELP

    MDR report key: 16493776 · Received March 7, 2023

    Report

    Report Number
    8010762-2023-00122
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    May 19, 2022
    Report Date
    July 20, 2023
    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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH HAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICE ON 2023-03-01: 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 2022-05-19. IT WAS REPORTED THAT THERE WAS A ORL/DENTAL HEMORRAGE (MAJOR BLEEDING). FURTHER INFORMATION REGARDING THE EVENT AND THE INVOLVED PRODUCT HAS BEEN REQUESTED BY GETINGE SALES AND SERVICE UNIT (SSU) HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER AFTER SEVERAL ATTEMPTS. BASED ON THE RESULTS THE REPORTED FAILURE "MAJOR BLEEDING DENTAL" COULD NOT BE CONFIRMED. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE CARDIOHELP DEVICE AS A SINGLE EVENT (TIMEFRAME FOR REVIEW BETWEEN 2022-03-01 AND 2023-03-01). 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 : NO FURTHER INFORMATION FROM CUSTOMER.

    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) 2023: 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) 2022. IT WAS REPORTED THAT THERE WAS A ORL/DENTAL HEMORRHAGE (MAJOR BLEEDING). 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
    717132 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening