BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 25041071 · Received April 30, 2026

    Report

    Report Number
    8010762-2026-0000202
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 19, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691718910
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. 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, ROTAFLOW CONSOLE¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K991864. 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 ROTAFLOW CONSOLE WITH CATALOG NUMBER 701046405.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT DURING THE TRANSFER OF A PATIENT TO THE CT ROOM USING A CENTRIFUGAL PUMP (EXTRACORPOREAL MEMBRANE OXYGENATION SYSTEM, ECMO) FOR EXAMINATION, THE ROTAFLOW CONSOLE EXPERIENCED A POWER OUTAGE. THE ROTAFLOW CONSOLE WAS SUBSEQUENTLY REPLACED WITH ANOTHER DEVICE WITH NO CONSEQUENCES FOR THE PATIENT. A PHONE CALL WITH THE CUSTOMER REVEALED THAT THEY HAD NOT CHECKED THE BATTERY LEVEL BEFORE USE AND HAD NOT REPLACED THE BATTERY WHEN IT EXCEEDED ITS SERVICE LIFE. NO HARM TO ANY PERSON HAS BEEN REPORTED. ON 2026-04-29 THE GETINGE SSU (SALES AND SERVICE UNIT) PROVIDE NEW INFORMATION AS FOLLOWS. THE BATTERY HAS NEVER BEEN REPLACED ON THIS DEVICE SINCE INSTALLATION IN 2021. THE CUSTOMER DID NOT ORDER ANY SERVICE OR REPAIR BY GETINGE THEREFORE NO ON-SITE INSPECTION CAN BE PERFORMED. DUE TO THE REPORTED EXCHANGE DURING PATIENT USE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279941 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706291#ROTAFLOW CHINESE ZH-PLUG 04037691718910

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention