BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOPUMP

    MDR report key: 9739825 · Received February 21, 2020

    Report

    Report Number
    1645362-2020-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    December 23, 2019
    Report Date
    February 21, 2020
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    Product Code
    KFM
    PMA / PMN Number
    K983272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED. IF PRODUCT IS RETURNED OR ADDITIONAL INFORMATION RECEIVED, A SUPPLEMENTAL REPORT SHALL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED BLOOD LEAKING FROM THE CENTRIFUGE PUMP DURING THE PROCEDURE.THE PROCEDURE WAS HALTED AND PUMP WAS REPLACED WITHOUT ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205613 FLOPUMP FLOPUMP KFM INTERNATIONAL BIOPHYSICS CORPORATION 012919-7190

    Patients

    Seq Age Sex Outcome Treatment
    1