BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMOSTOP

    MDR report key: 1673676 · Received April 28, 2010

    Report

    Report Number
    1673676
    Event Type
    Malfunction
    Date Received
    April 28, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 28, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS POST HEART CATH PROCEDURE AND IN ICU FOR ARTERIAL LINE/FEMORAL SHEATH REMOVAL. THE RN PULLED THE FEMORAL SHEATH WITH A FEMOSTOP. THE BULB INFLATED BUT WOULD NOT HOLD PRESSURE. THE FEMOSTOP WAS FROM LOT #879762. STAFF GOT ANOTHER FEMOSTOP WITH A LOT #878439 WHICH ALSO FAILED. FINALLY A FEMOSTOP WITH A DIFFERENT LOT NUMBER WAS USED AND WORKED APPROPRIATELY. THE RN REPORTED THAT ANOTHER ICU UNIT HAD ALSO HAD A SIMILAR EXPERIENCE WITH A FEMOSTOP WITH THE LOT #879762. THE PATIENT EXPERIENCED MINOR BLEEDING. ALL THE PRODUCT WAS PULLED FROM THE SHELVES AND IS BEING HELD BY MATERIALS MANAGEMENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE BULB WOULD NOT STAY INFLATED SO WOULD NOT PROVIDE THE COMPRESSION-ASSIST FOR VASCULAR CLOSURE.====================== MANUFACTURER RESPONSE ======================MATERIALS MANAGEMENT HAS COLLECTED THE MALFUNCTIONING DEVICES AND SAID THAT THEY WERE NOTIFYING THE MANUFACTURER. MANUFACTURER IS COMING TO THE FACILITY TO LOOK INTO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMOSTOP CLAMP, VASCULAR, REPROCESSED NMF ASCENT HEALTHCARE SOLUTIONS * 879762 & 878439

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR