BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOHELP

    MDR report key: 21751885 · Received April 2, 2025

    Report

    Report Number
    3013876692-2025-00024
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    December 12, 2024
    Report Date
    April 4, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691658384
    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

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE SPAIN MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, CARDIOHELP¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K133598. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR CARDIOHELP WITH CATALOG NUMBER 701048012.

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH WAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES ON 2025-03-31: 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) 2024 WITH REPORT NUMBER PS/TS/118939. THE INFORMATION WAS PROVIDED THAT THE PATIENT HAD THE INCIDENT " LEFT-SIDED HEART FAILURE. PULMONARY EDEMA" AND THE CONSEQUENCE FOR THE PATIENT WAS " NEED FOR MEDICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. OROTRACHEAL INTUBATION AND CHANGE IN VENTRICULAR DELIVERY METHOD ON PERIPHERAL VA ECMO: IABP WITHDRAWAL AND IMPELLA CP IMPLANTATION. RENACER REGISTRY PATIENT (B)(6). PATIENT IN RECOVERY.¿ NEW INFORMATION WAS RECEIVED ON 2025-04-02 THAT NEITHER THE CARDIOHELP DEVICE NOR THE DISPOSABLE WERE AFFECTED AND THAT NO DEVICE MALFUNCTION OCCURRED. THE CARDIOHELP DEVICE HAD SEVERAL ROUTINE CHECK UPS SINCE THE EVENT AND NO MALFUNCTION WAS OBSERVED. BASED ON THE AVAILABLE INFORMATION THE REPORTED EVENT "LEFT-SIDED HEART FAILURE. PULMONARY EDEMA" COULD NOT BE LINKED TO A DEVICE DEFECT/FAILURE. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE CONFIRMATION WAS RECEIVED THAT THERE WAS NO PRODUCT MALFUNCTION ON A GETINGE PRODUCT, THEREFORE THIS COMPLAINT IS NOT REPORTABLE 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.

    Description of Event or Problem · 0

    MAQUET CARDIOPULMONARY GMBH WAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES ON 2025-03-31: 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 2024-12-12. THE INFORMATION WAS PROVIDED THAT THE PATIENT HAD THE INCIDENT " LEFT-SIDED HEART FAILURE. PULMONARY EDEMA" AND THE CONSEQUENCE FOR THE PATIENT WAS " NEED FOR MEDICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. OROTRACHEAL INTUBATION AND CHANGE IN VENTRICULAR DELIVERY METHOD ON PERIPHERAL VA ECMO: IABP WITHDRAWAL AND IMPELLA CP IMPLANTATION. PATIENT IN RECOVERY.¿ COMPLAINT ID # (B)(4).

    Description of Event or Problem · 0

    THE CONFIRMATION WAS RECEIVED THAT THERE WAS NO PRODUCT MALFUNCTION ON A GETINGE PRODUCT, THEREFORE THIS COMPLAINT IS NOT REPORTABLE. COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632884 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L