BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOPUMP

    MDR report key: 5695256 · Received June 2, 2016

    Report

    Report Number
    1645362-2016-00003
    Event Type
    Injury
    Date Received
    June 2, 2016
    Date of Event
    February 17, 2016
    Report Date
    June 2, 2016
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    Product Code
    KFM
    UDI-DI
    00814321020001
    PMA / PMN Number
    K983272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER AND NOT RETURNED FOR EVALUATION. THE USER STATED THAT THE PRODUCT WAS NOT BEING USED IN A MANNER CONSISTENT WITH THE INSTRUCTIONS FOR USE. THE USER STATED THAT THE PRODUCT WAS USED LONGER THAN SIX (6) HOURS WHICH IS CONSIDERED OFF-LABEL USE FOR THIS DEVICE.

    Description of Event or Problem · 1

    PER CUSTOMER INFORMATION, THE PRODUCT CAUSED HIGH HEMOLYSIS IN A PATIENT. ACCORDING TO USER, DEVICE WAS BEING USED FOR EXTENDED PERIOD OF TIME, LONGER THAN SIX (6) HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348925 FLOPUMP FLOPUMP KFM INTERNATIONAL BIOPHYSICS CORPORATION UNKNOWN 00814321020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other