BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 20333229 · Received September 30, 2024

    Report

    Report Number
    1220648-2024-18754
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 8, 2024
    Report Date
    October 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF OPTICAL SIGNAL ISSUE HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE CANNOT BE DETERMINED AS LIMITED CLINICAL DETAILS AND INSUFFICIENT PRODUCT AND DATA LOGS WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION HAS BEEN COMPLETED. NO PRODUCT WAS RETURNED FOR EVALUATION. DATA LOGS WERE ONLY AVAILABLE FOR UP TO DAY THREE OF SUPPORT AND NOT AT TIME OF REPORTED ISSUE. CLINICAL DETAILS NOTED THAT CLINICAL TEAM WAS CONCERNED ABOUT THE VALIDITY OF THE SENSOR AS THE PLACEMENT SIGNAL READING WAS DIFFERENT THAN THE PATIENT'S ACTUAL BLOOD PRESSURE READINGS. THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE CANNOT BE DETERMINED AS LIMITED CLINICAL DETAILS AND INSUFFICIENT PRODUCT AND DATA LOGS WERE PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT PRODUCT AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME THE PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME. B1 ADVERSE EVENT UPDATED. B2 UPDATED TO DEATH. B5 UPDATED TO INCLUDE DEATH. H1 UPDATED TO DEATH. H6 UPDATED TO INCLUDE DEATH AND OPTICAL SIGNAL CODING. B7 OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS UPDATED. G1 REPORTING CONTACT EMAIL UPDATED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA CP SUPPORT AND THERE WERE PLACEMENT SIGNAL ISSUES. THE DOCTOR WAS QUESTIONING THE VALIDITY OF THE SENSOR ON THE DEVICE SO THE PUMP WAS REPLACED WITH AN IMPELLA 5.5. THE PATIENTS OUTCOME IS UNKNOWN.

    Description of Event or Problem · 0

    CARE WAS EVENTUALLY WITHDRAWN, AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582612 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024429577 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death