BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 7600521 · Received June 5, 2018

    Report

    Report Number
    7600521
    Event Type
    Death
    Date Received
    June 5, 2018
    Date of Event
    February 10, 2018
    Report Date
    June 1, 2018
    Manufacturer
    ABIOMED
    Product Code
    PBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMPELLA ALARMED WITH SCREEN SHOWING "IMPELLA STOPPED / RETROGRADE FLOW" P-LEVEL DROPPED TO 0. NO KINKS OR DISCONNECTS NOTED. DESPITE CHANGING WHITE CABLES AND CONTACTING IMPELLA REP FOR GUIDANCE, PT DETERIORATED AND EXPIRED DESPITE ALL RESUSCITATIVE EFFORTS. CRITICALLY ILL PT IN ICU ON IMPELLA SUPPORT. ON (B)(6) 2018, IMPELLA ALARMS SOUNDED AND SCREEN SHOWED "IMPELLA STOPPED, RETROGRADE FLOW." IMPELLA INITIALLY AT P-LEVEL 6 BUT DROPPED TO P-LEVEL 0 WITH IMPELLA FLOW + 0.00L/MIN. ATTEMPTS WERE MADE TO DIAL UP THE P-LEVEL BACK TO 6 BUT DEVICE CONTINUED TO DROP TO 0. DEVICE ASSESSED FOR DISCONNECTS AND KINKS. IMPELLA REP CONTACTED, WHITE CABLES CHANGED. PT BECAME HEMODYNAMICALLY UNSTABLE, CPR INITIATED. PT EXPIRED DESPITE ALL RESUSCITATIVE EFFORTS. DEVICE WAS IMMEDIATELY TURNED OVER TO THE MFR'S REP FOR INVESTIGATION. RECENTLY RECEIVED REPORT FROM A BIOMED DATED (B)(6) 2018 INDICATING THAT A COIL SHORT IN THE IMPELLA CATHETER WAS LIKELY THE SOURCE OF THE PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411593 IMPELLA CP IMPELLA CP PBL ABIOMED

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death IMPELLA CATHETER| IMPELLA CONTROLLER: SERIAL # (B)(4) USED WITH