BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23086455 · Received September 18, 2025

    Report

    Report Number
    1220648-2025-31557
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    September 6, 2024
    Report Date
    September 18, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION OF THE PLACEMENT SIGNAL ISSUE HAS BEEN COMPLETED. IMPELLA CP RETURNED FOR EVALUATION. AS THE IMPELLA CP DOES NOT HAVE A DIFFERENTIAL PRESSURE SENSOR, THE FAILURE MODE INVESTIGATED WAS CHANGED FROM "PLACEMENT SIGNAL ISSUE" TO "OPTICAL SIGNAL ISSUE" DUE TO THE FAILURE MODE OF "PLACEMENT SIGNAL ISSUE" ONLY BEING USED FOR ISSUES RELATED TO THE DIFFERENTIAL PRESSURE SENSOR. UPON VISUAL INSPECTION NO ABNORMALITIES WERE NOTED. PUMP PASSED LASER CONTINUITY TEST AND NO BIOMATERIAL WAS PRESENT. DATA LOGS FROM FIELD WERE RETURNED AND SHOWED SLOWLY DROP TO NEAR 0 OVER APPROXIMATELY 50 MINUTES BEFORE RISING TO A NORMAL RANGE. THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE CANNOT BE DETERMINED AS NO ISSUES WERE NOTED WITH RETURNED PUMP AND LIMITED CLINICAL DETAILS WERE PROVIDED ON PATIENT'S CONDITION. 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.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A CP PUMP WAS USED TO SUPPORT A PATIENT UNDERGOING HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION. DURING SUPPORT, THE PLACEMENT SIGNAL WAS UNRELIABLE. DESPITE THIS, THE PUMP REMAINED OPERATIONAL UNTIL WEANING AND EXPLANTATION. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2842206 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025531369 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male AUTOMATED IMPELLA CONTROLLER