BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART LUNG MACHINE

    MDR report key: 25091243 · Received May 6, 2026

    Report

    Report Number
    8010762-2026-0000213
    Event Type
    Death
    Date Received
    May 6, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 6, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (ROTAFLOW) HAS BEEN MANUFACTURED ON 2009. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT DURING AN INTERNAL HOSPITAL TRANSPORT OF A PATIENT, THE ROTAFLOW CONSOLE RAN OUT OF POWER (SHUT DOWN). THE PERFUSIONIST BRIEFLY CONNECTED THE CENTRIFUGAL PUMP TO THE EMERGENCY DRIVE AND SWITCHED TO ANOTHER ROTAFLOW CONSOLE. THE DEFECTIVE ROTAFLOW CONSOLE COULD BE SWITCHED ON IF THE SWITCH WAS PRESSED FOR A LONG TIME. THE AFFECTED CONSOLE IS CURRENTLY LOCATED IN THE FIELD OF CARDIOTECHNOLOGY. ACCORDING TO THE CUSTOMER THE PATIENT LATER EXPIRED, UNRELATED TO THE FAILURE. ON 2026-05-04 THE GETINGE SSU (SALES AND SERVICE UNIT) PROVIDED INFORMATION ABOUT THE EVENT AS FOLLOWS: THE PATIENT UNDERWENT SURGERY IN THE NEUROSURGERY DEPARTMENT. (RFC WAS CONNCTED TO AC POWER) PATIENT WAS TRANSFERED TO THE CT SCANNER FOR MONITORING (DURING CT THE RFC WAS CONNCTED TO AC POWER). FROM THE CT SCAN BACK TO THE INTENSIVE CARE UNIT THE RFC SHUT DOWN. THE POWER SWITCH WAS IN THE ON POSITION. CUSTOMER DID NOT TOUCH THIS SWITCH. AFTERWARDS THE DEVICE COULD NOT BE RESTARTED. HAND CRANK WAS USED AND THE DEVICE WAS SWITCHED TO ANOTHER DEVICE. THE BATTERY WAS FULLY CHARGED. DUE TO THE REPORTED EXCHANGE OF THE DEVICE AND THE REPORTED DEATH OF THE PATIENT A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66028 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706051#ROTAFLOW GERMAN EU-PLUG

    Patients

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