BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP

    MDR report key: 20219547 · Received September 14, 2024

    Report

    Report Number
    1220648-2024-17831
    Event Type
    Malfunction
    Date Received
    September 14, 2024
    Date of Event
    July 30, 2022
    Report Date
    May 13, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502011029
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN IDENTIFIED AS PART OF A RETROSPECTIVE REVIEW. DUE TO THE LIMITED CLINICAL INFORMATION AND LACK OF AVAILABLE DATA/PRODUCT THE ROOT CAUSE OF THIS INVESTIGATION IS NOT DETERMINED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. SECTION: CLEANING ¿DO NOT CLEAN WITH OR EXPOSE ANY PART OF THE CLEAR SIDEARM OF THE IMPELLA CATHETER (EG, INFUSION FILTER, PRESSURE RESERVOIR) TO ALCOHOL. ALCOHOL HAS BEEN SHOWN TO CAUSE CRACKS AND LEAKS IN THESE COMPONENTS. CAREFULLY READ LABELS ON COMMON SKIN PREPS AND LOTIONS TO AVOID USING ANY ALCOHOL-CONTAINING PRODUCTS IN THE AREA OF THE INFUSION FILTER OR PRESSURE RESERVOIR.¿. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT POST CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT'S MOVEMENT RESULTED IN A BREAK LOCATED DIRECTLY BETWEEN THE PURGE FILTER AND RESERVOIR WHICH PROMPTED THE NEED FOR A BYPASS AS THE PUMP IS STILL NEEDED OF RP SUPPORT. THE INTENSIVE CARE UNIT STAFF PERFORMED THE PURGE FILTER/RESERVOIR BYPASS WITH NO PROBLEMS AND PURGE FLOWS AND PRESSURES REMAINED OPTIMAL. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666164 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP 2022065821 00813502011029

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male