BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART LUNG MACHINE

    MDR report key: 15335143 · Received September 1, 2022

    Report

    Report Number
    3008355164-2022-00025
    Event Type
    Death
    Date Received
    September 1, 2022
    Date of Event
    June 13, 2022
    Report Date
    September 20, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW UP REPORT TO COMPLAINT (B)(4) WHICH WAS REPORTED UNDER MFR# 8010762-2022-00353 ON 2022-09-01. GETINGE HAS BEEN RECEIVED NEW INFORMATION ON 2022-09-13 BY THE SSU (SALES AND SERVICE UNIT) IN REGARDS THE INVOLVED PRODUCT THEREFORE, THE REPORTING DECISION CHANGED FROM REPORTABLE TO NON REPORTABLE. THIS COMPLAINT WAS MIS-DELIVERED FROM MFDS (MINISTRY OF FOOD AND DRUG SAFETY) SOUTH KOREA, STATED WITH A THIRD-PARTY COMPANY¿S PRODUCT, WHICH IS MITRACLIP MANUFACTURED BY ABBOTT. IN THE REPORTED ADVERSE EVENT, THERE WAS NO GETINGE PRODUCT INVOLVED. THE COMPLAINT INFORMATION HAS BEEN SUBMITTED TO THE LEGAL MANUFACTURER ABBOTT. AS GETINGE IS NOT THE LEGAL MANUFACTURER OF THE REPORTED PRODUCT THIS IS NOT CONSIDERED AS A CUSTOMER PRODUCT COMPLAINT ACCORDING TO THE DEFINITION OF THE COSTUMER PRODUCT COMPLAINT HANDLING PROCESS THEREFORE THIS COMPLAINT WILL BE CANCELLED.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN SOUTH KOREA. IT WAS REPORTED THAT ON (B)(6) 2020, MITRACLIP WAS IMPLANTED AND ON (B)(6) 2022, THE PATIENT DIED. ACCORDING TO THE ATTENDING PHYSICIAN, THE DEATH WAS NOT RELATED TO THE MITRACLIP OR MITRACLIP PROCEDURE. THE SERIAL NUMBER MENTIONED IN THE COMPLAINT BELONGS TO A ROTAFLOW. NO ADDITIONAL INFORMATION WAS RECEIVED. FURTHER INFORMATION ABOUT THE EVENT WAS REQUESTED BUT IS STILL PENDING. REF- 681003.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824134 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW ENGLISH EU-PLUG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death