BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24376552 · Received February 18, 2026

    Report

    Report Number
    1220648-2026-03396
    Event Type
    Death
    Date Received
    February 18, 2026
    Date of Event
    October 2, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    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

    CORRECTION. COMPLAINT/PATIENT CODING WAS UPDATED/CORRECTED AS FOLLOWS: ADDED MEDICATION REQUIRED (E2403). THEREFORE, SECTION H6 (HEALTH EFFECT ¿ CLINICAL CODE, HEALTH EFFECT ¿ IMPACT CODE, AND MEDICAL DEVICE PROBLEM CODE) HAS BEEN FULLY REPOPULATED AND SHOULD BE REGARDED AS THE CODING THAT ACCURATELY REFLECTS THE REPORTED EVENT. ADDITIONAL INFORMATION NOTED THE IMPELLA DEVICE WAS RECEIVED, AND AN EVALUATION/ANALYSIS IS UNDERWAY. UPON COMPLETION OF THE EVALUATION/ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. CORRESPONDINGLY, SECTIONS D9: DEVICE RECEIVED BY MANUFACTURER WITH RECEIPT DATE AND H6: INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODES WERE UPDATED ACCORDINGLY. 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.

    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.

    Description of Event or Problem · 0

    DURING IMPELLA SET UP, A HIGH PURGE PRESSURE ALARM WENT OFF. THIS WAS RESOLVED WITH RECONNECTING YELLOW CONNECTERS HOWEVER OCCURRED AGAIN DURING IMPELLA CP SUPPORT. TPA WAS ADMINISTERED AND ALARM WAS CLOSELY MONITORED. FAMILY CHOSE TO WITHDRAW CARE. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS DUE TO IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524566 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026695296 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death