BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING SET

    MDR report key: 16970037 · Received May 19, 2023

    Report

    Report Number
    3008355164-2023-00019
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    March 29, 2023
    Report Date
    June 15, 2023
    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 2023-05-12: 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 2023-03-29. THE INFORMATION WAS PROVIDED THAT THE PATIENT SUFFERED AN EDEMATIZATION OF THE RIGHT LOWER EXTREMITY ASSOCIATED WITH AN INTRAMUSCULAR HEMATOMA. ON 20223-06-06 THE CUSTOMER CONFIRMED THAT NEITHER THE CARDIOHELP, HLS SET, NOR THE HLS CANNULAS ARE INVOLVED IN THE EVENT. BASED ON THE AVAILABLE INFORMATION THE REPORTED EVENT " PATIENT SUFFERED AN EDEMATIZATION OF THE RIGHT LOWER EXTREMITY ASSOCIATED WITH AN INTRAMUSCULAR HEMATOMA" 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 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 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 : HLS SET DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 0

    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 2023-05-12: 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)2023. THE INFORMATION WAS PROVIDED THAT THE PATIENT SUFFERED AN EDEMATIZATION OF THE RIGHT LOWER EXTREMITY ASSOCIATED WITH AN INTRAMUSCULAR HEMATOMA." COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075506 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 7050 #SHLS SET ADVANCED 7.0 3000239766

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening