BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 11071799 · Received December 24, 2020

    Report

    Report Number
    11071799
    Event Type
    Injury
    Date Received
    December 24, 2020
    Date of Event
    November 20, 2020
    Report Date
    December 10, 2020
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    THIS PATIENT WAS ON AN IMPELLA PUMP. AT NIGHT, THE IMPELLA CONTROLLER SOUNDED AN ALARM AND DISPLAYED TWO ERROR MESSAGES: "IMPELLA STOPPED: CONTROLLER FAILURE" AND "IMPELLA STOPPED: RETROGRADE FLOW", AND SUBSEQUENTLY CONTINUALLY DISPLAYED THE MESSAGE "CONTROLLER ERROR". AS THE CONTROLLER WAS MALFUNCTIONING THE P-LEVEL AUTOMATICALLY DROPPED TO P-0. WE CONFIRMED THE CM PLACEMENT OF THE IMPELLA CATHETER, AT FELT FOR A PULSE, BUT WITHOUT THE IMPELLA SUPPORT THE PATIENT HAD LOST HIS PULSE AND WE BEGAN A CODE. DURING THE CODE AND DURING THE DISPLAY OF ERROR MESSAGES WE SPOKE WITH THE IMPELLA REPRESENTATIVE ON THE PHONE (SHE WAS ABLE TO REMOTELY SEE THE IMPELLA SCREEN TO MONITOR THE DEVICE IN REAL-TIME), AND AT EARLY MORNING, I SUBSEQUENTLY SPOKE WITH ANOTHER PERSON FROM IMPELLA TO UPDATE HER AS WELL. WE SEQUESTERED THE CONTROLLER AND WILL NOTE FOR IT TO BE ASSESSED AND SERVICED.

    Description of Event or Problem · 1

    THIS PATIENT WAS ON AN IMPELLA PUMP. AT NIGHT, THE IMPELLA CONTROLLER SOUNDED AN ALARM AND DISPLAYED TWO ERROR MESSAGES: "IMPELLA STOPPED: CONTROLLER FAILURE" AND "IMPELLA STOPPED: RETROGRADE FLOW", AND SUBSEQUENTLY CONTINUALLY DISPLAYED THE MESSAGE "CONTROLLER ERROR". AS THE CONTROLLER WAS MALFUNCTIONING THE P-LEVEL AUTOMATICALLY DROPPED TO P-0. WE CONFIRMED THE CM PLACEMENT OF THE IMPELLA CATHETER, AT FELT FOR A PULSE, BUT WITHOUT THE IMPELLA SUPPORT THE PATIENT HAD LOST HIS PULSE AND WE BEGAN A CODE. DURING THE CODE AND DURING THE DISPLAY OF ERROR MESSAGES WE SPOKE WITH THE IMPELLA REPRESENTATIVE ON THE PHONE (SHE WAS ABLE TO REMOTELY SEE THE IMPELLA SCREEN TO MONITOR THE DEVICE IN REAL-TIME), AND AT EARLY MORNING, I SUBSEQUENTLY SPOKE WITH ANOTHER PERSON FROM IMPELLA TO UPDATE HER AS WELL. WE SEQUESTERED THE CONTROLLER AND WILL NOTE FOR IT TO BE ASSESSED AND SERVICED.

    Description of Event or Problem · 1

    THIS PATIENT WAS ON AN IMPELLA PUMP. AT NIGHT, THE IMPELLA CONTROLLER SOUNDED AN ALARM AND DISPLAYED TWO ERROR MESSAGES: "IMPELLA STOPPED: CONTROLLER FAILURE" AND "IMPELLA STOPPED: RETROGRADE FLOW", AND SUBSEQUENTLY CONTINUALLY DISPLAYED THE MESSAGE "CONTROLLER ERROR". AS THE CONTROLLER WAS MALFUNCTIONING THE P-LEVEL AUTOMATICALLY DROPPED TO P-0. WE CONFIRMED THE CM PLACEMENT OF THE IMPELLA CATHETER, AT FELT FOR A PULSE, BUT WITHOUT THE IMPELLA SUPPORT THE PATIENT HAD LOST HIS PULSE AND WE BEGAN A CODE. DURING THE CODE AND DURING THE DISPLAY OF ERROR MESSAGES WE SPOKE WITH THE IMPELLA REPRESENTATIVE ON THE PHONE (SHE WAS ABLE TO REMOTELY SEE THE IMPELLA SCREEN TO MONITOR THE DEVICE IN REAL-TIME), AND AT EARLY MORNING, I SUBSEQUENTLY SPOKE WITH ANOTHER PERSON FROM IMPELLA TO UPDATE HER AS WELL. WE SEQUESTERED THE CONTROLLER AND WILL NOTE FOR IT TO BE ASSESSED AND SERVICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537285 IMPELLA TEMPORARY NON-ROLLER TYPE CARDIAC SUPPORT BLOOD PUMP OZD ABIOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31025 DA Life Threatening| R