BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23888927 · Received December 24, 2025

    Report

    Report Number
    1220648-2025-49318
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    September 27, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: HYPOVOLEMIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PUMP SUCTION: CLINICAL REPORTED SUCTION THAT RESOLVED WITH PRBC'S. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. DATA LOG REVIEW CONFIRMS SUCTION ALARMS TRIGGERING. AT THIS TIME, PLACEMENT SIGNAL DROPPED AND STARTED TO TREND DOWN. PLACEMENT SIGNAL THEN STARTED TO SLOWLY INCREASE AGAIN, WHICH WAS LIKELY DUE TO ALBUMIN AND PRBCS BEING GIVEN. THE CAUSE OF THE SUCTION WAS MOST LIKELY RELATED TO THE PATIENTS CONDITION, AS PLACEMENT SIGNAL WAS TRENDING DOWN PRIOR TO VOLUME ADMINISTRATION, AND CLINICAL REPORTED THE PATIENT WAS IN POOR CONDITIONS. HEMOLYSIS: CLINICAL REPORTED HEMOLYSIS OCCURRING WHICH LED TO DECISION TO REMOVE THE PUMP. THE PUMP WAS IN PROPER POSITIONING. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. DATA LOG REVIEW SHOWS A DOWNWARD TREND IN PLACEMENT SIGNAL AND CLINICAL STATED THE PATIENT WAS IN POOR CONDITION. THERE WERE NO POSITIONING ISSUES OR MOTOR CURRENT SPIKES OBSERVED. THE CAUSE OF THE HEMOLYSIS WAS MOST LIKELY RELATED TO THE PATIENTS CONDITION, AS PLACEMENT SIGNAL WAS TRENDING DOWN PRIOR TO VOLUME ADMINISTRATION, AND CLINICAL REPORTED THE PATIENT WAS IN POOR CONDITIONS. DEVICE HISTORY LOT: DEVICE LOT NUMBER: 1954317 DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A DEVICE HISTORY REVIEW: PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CRITERIA.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT LOST PULSATILITY WHICH WAS RESOLVED WITH ALBUMIN ADMINISTRATION. SUCTION ALSO OCCURRED, WHICH WAS RESOLVED WITH PACKED RED BLOOD CELLS. HEMOLYSIS WAS ALSO REPORTED, WITH ECHOCARDIOGRAPHY CONFIRMING SATISFACTORY POSITION. STAFF EVENTUALLY DECIDED TO EXPLANT THE PUMP. THE PATIENT¿S OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918472 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026711267 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention