BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING SET

    MDR report key: 16617734 · Received March 27, 2023

    Report

    Report Number
    8010762-2023-00146
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    May 19, 2022
    Report Date
    April 27, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Product Problem
    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 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 2023-03-21: 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. THE INFORMATION WAS PROVIDED THAT THE INCIDENT WAS A STROKE." ON 2023-04-20 THE INFORMATION FROM THE CUSTOMER WAS RECEIVED THAT THE CUSTOMER IS NOT AWARE OF ANY IMPLANTS ON (B)(6) 2022, NOR DID THE CUSTOMER REPORTED ANY STROKE TO WHERE A PATIENT WAS CONNECTED TO AN ECMO. THEREFORE NO MORE INFORMATION COULD BE PROVIDED BY THE CUSTOMER IN REGARDS TO THE PRODUCT OR ANY EVENT, TO ENABLE ANY INVESTIGATION FROM THE MANUFACTURER. BASED ON THE AVAILABLE INFORMATION THE REPORTED EVENT "STROKE" COULD NOT BE CONFIRMED. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS AS A SINGLE EVENT (TIMEFRAME FROM 2022-03-21 TILL 2023-03-21). THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. THE OCCURRENCE RATE RELATED TO THE REPORTED EVENT 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 : ACCORDING TO THE CUSTOMER THE EVENT NOT HAPPENED.

    Description of Event or Problem · 0

    MAQUET CARDIOPULMONARY GMBH HAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICE ON 2023-03-21: 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. THE INFORMATION WAS PROVIDED THAT THE INCIDENT WAS A STROKE." 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
    835577 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 7050 #SHLS SET ADVANCED 7.0 3000270719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening