BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 24685542 · Received March 25, 2026

    Report

    Report Number
    8010762-2026-0000143
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 21, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION WAS RECEIVED ON 2026-03-27 THAT THE CARDIOHELP WAS REPLACED DURING TREATMENT. THE FAILURE WAS THAT THE PRESSURE READINGS WERE TOO HIGH. THE CUSTOMER DECLINED TO DISCLOSE PATIENT DATA. FURTHER IT WAS STATED BY THE CUSTOMER THAT THE PUMP DID NOT STOP. THE HLS CABLE WAS CORRODED. A PICTURE EVIDENCE WAS PROVIDED. A GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE CHINESE 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.

    Description of Event or Problem · 0

    COMPLAINT ID# (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN CHINA DURING TREATMENT. IT WAS REPORTED THAT AN ERROR WAS FOUND IN THE MONITORING OF ARTERIAL PRESSURE VALUES. UPON INSPECTION THE GETINGE FIELD SERVICE TECHNICIAN FOUND THAT THE HLS CABLE NEEDED TO BE REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE, CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289164 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1