BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24612853 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05395
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    November 18, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A 75 YEAR OLD MALE WAS TREATED FOR AN ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. AN IMPELLA CP WAS PLACED AND THE PATIENT TRANSFERRED TO THE INTENSIVE CARE WARD ON SUPPORT. DUE TO A SMALL VENTRICULAR CAVITY, THE PUMP WAS NOTED TO BE SLIGHTLY SHALLOW. INTERMITTENT "IMPELLA IN AORTA" ALARMS WERE NOTED BUT FOUND TO BE INACCURATE, FALSE ALARM, CONFIRMED BY ECHOCARDIOGRAPHY. AFTER TWO DAYS OF SUPPORT, THE IMPELLA CP WAS SUCCESSFULLY WEANED AND REMOVED. THE PUMP WAS REMOVED IN THE OPERATION THEATER BY SURGICAL CUT-DOWN. DURING IMPELLA CP SUPPORT THE PATIENT EXPERIENCED A FALSE ALARM. INTERMITTENT INACCURATE "IMPELLA IN AORTA" ALARMS WHILE COMPLETING ECHO IMAGING. THERE WAS NO PATIENT CONSEQUENCE. THIS IS CONSIDERED A REPORTABLE MALFUNCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674070 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026753602

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male