BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA MAX PUMP - INDIGO SYSTEM

    MDR report key: 7813169 · Received August 23, 2018

    Report

    Report Number
    MW5079375
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    August 21, 2018
    Report Date
    August 22, 2018
    Manufacturer
    PENUMBRA INC., USA
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SALVAGEABLE BLOOD LOSS DURING ENDOVASCULAR REPAIR OF RIGHT DISTAL ILIAC PROXIMAL COMMON FEMORAL ARTERY DISSECTION AND MECHANICAL THROMBECTOMY USING K160449 TRADE/DEVICE NAME: PENUMBRA SYSTEM AND PENUMBRA PUMP MAX REGULATION NUMBER: 21 CFR 870.1250, THE BLOOD LOST DURING ASPIRATION OF CLOT IS COLLECTED IN A SUCTION PUMP - PENUMBRA MAX PUMP, IN A CLOSED SYSTEM. I AM INFORMED BY THE REP THAT BLOOD IS NOT SALVAGEABLE BECAUSE THE SYSTEM IS NOT STERILE. THAT IS NOT ACCEPTABLE. THAT BLOOD SHOULD BE EASILY SALVAGEABLE IF THE CONTAINER IS STERILE AND THE CLOTS ARE FILTERED OUT. OR IT SHOULD BE MADE ACCESSIBLE FOR USE WITH A CELL SAVER. PTS ARE ROUTINELY HEPARINIZED DURING THESE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652713 PENUMBRA MAX PUMP - INDIGO SYSTEM CATHETER, THROMBUS, RETRIEVER NRY PENUMBRA INC., USA PMX110

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other