BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOHELP

    MDR report key: 15923681 · Received December 6, 2022

    Report

    Report Number
    3008355164-2022-00034
    Event Type
    Death
    Date Received
    December 6, 2022
    Date of Event
    March 3, 2022
    Report Date
    March 21, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K133598
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SP
    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.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN SPAIN. FOLLOWING WAS INITIALLY REPORTED: ¿ INCIDENT DESCRIPTION: ¿MAJOR BLEEDING. PERIPHERAL VASCULAR CATHETER¿. CONSEQUENCES FOR THE PATIENT: ¿DEATH¿. THE EVENT WAS REPORTED TO THE AUTHORITIES BY THE CUSTOMER. (AUTHORITY REFERENCE (B)(4)) FURTHER INFORMATION REGARDING THE EVENT AND THE INVOLVED PRODUCT HAS BEEN REQUESTED BY GETINGE SALES AND SERVICE UNIT (SSU). HOWEVER, NO FURTHER INFORMATION CAN BE PROVIDED BY THE CUSTOMER. BASED ON THE RESULTS THE REPORTED EVENT COULD NOT BE CONFIRMED. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE CARDIOHELP DEVICE AS A SINGLE EVENT (TIMEFRAME FROM 2021-11-28 AND 2022-11-28). 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: IF NEW RELEVANT INFORMATION BECOME AVAILABLE, THE COMPLAINT WILL RE-OPENED AND FURTHER INVESTIGATION STEPS WILL BE INITIATED.

    Description of Event or Problem · 0

    FOLLOWING WAS INITIALLY REPORTED: ¿ INCIDENT DESCRIPTION: ¿MAJOR BLEEDING. PERIPHERAL VASCULAR CATHETER¿. CONSEQUENCES FOR THE PATIENT: ¿DEATH¿ ". 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
    1742655 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Death