BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24313813 · Received February 11, 2026

    Report

    Report Number
    1220648-2026-02869
    Event Type
    Death
    Date Received
    February 11, 2026
    Date of Event
    October 6, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 AND D4. HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: THE CAUSE OF THE HEMOLYSIS WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND LACK OR DATA AND PRODUCT RETURNED.

    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. CORRECTED INFORMATION WAS PROVIDED IN B1. UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4. UPON REVIEW, THE CATALOG AND PRIMARY UDI NUMBER HAVE BEEN UPDATED.

    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

    D1. BRAND NAME CORRECTED.

    Description of Event or Problem · 0

    A 62-YEAR-OLD MAN WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE AND COCAINE USE PRESENTED AFTER A VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION CARDIAC ARREST. UPON ARRIVAL, THE PATIENT WAS DIAGNOSED WITH CARDIOGENIC SHOCK. THE PATIENT WAS CANNULATED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), AFTER WHICH AN IMPELLA CP WAS PLACED WITHOUT COMPLICATION. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND BEDSIDE ECHOCARDIOGRAPHY DEMONSTRATED AN IMPROPER IMPELLA POSITION BEING DEEPER THAN RECOMMENDED PER THE INSTRUCTIONS FOR USE MANUAL. URINE OUTPUT APPEARED CLEAR, AND THE CLINICAL DECISION WAS MADE TO MAINTAIN THE DEVICE IN PLACE. ON THE SECOND DAY OF SUPPORT, THE LACTATE DEHYDROGENASE LEVEL WAS ELEVATED; A REPEAT SPECIMEN WAS DRAWN DUE TO AN INITIAL HEMOLYZED SAMPLE. THE PATIENT RECEIVED A BLOOD TRANSFUSION. THE IMPELLA DEVICE WAS REPOSITIONED UNDER ECHOCARDIOGRAPHIC GUIDANCE AFTER A SUCTION ALARM OCCURRED. OPTIMAL POSITIONING WAS ACHIEVED FOLLOWING ADJUSTMENT. ON THE FOURTH DAY OF SUPPORT, THE PATIENT EXPIRED WHILE ON MECHANICAL CIRCULATORY SUPPORT WHICH IS MORE LIKELY DUE TO THE PATIENT'S UNDERLYING COMPLICATED CLINICAL PROFILE WHILE DEATH WILL CONSERVATIVELY BE CODED TO THE IMPELLA CP. NO DEVICE MALFUNCTION WAS REPORTED, AND ALL DEVICE-RELATED DECISIONS WERE BASED ON THE PATIENT¿S CLINICAL CONDITION AND RESPONSE TO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377768 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026731057 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death| R