BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART LUNG MACHINE

    MDR report key: 14373295 · Received May 12, 2022

    Report

    Report Number
    3008355164-2022-00013
    Event Type
    Death
    Date Received
    May 12, 2022
    Report Date
    May 12, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE INITIAL IMPORTER REPORT- (B)(4) TO COMPLAINT (B)(4) THAT WAS INITIALLY REPORTED UNDER MFR. REPORT# 8010762-2022-00153 ON (B)(6) 2022 AS A MALFUNCTION (NOW BEING REPORTED AS A DEATH) WHICH IS A DUPLICATE ENTRY TO COMPLAINT (B)(4), REPORTED UNDER MFR. REPORT# 8010762-2022-00150 ON (B)(6) 2022 AND (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISPLAYED FLOW OF THE ROTAFLOW IS UNDER DELIVERING SETTING WHERE AT 5 LPM. THE FAILURE OCCURRED DURING PATIENT TREATMENT. REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040955 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW ENGLISH/US US-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death