BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24642847 · Received March 19, 2026

    Report

    Report Number
    1220648-2026-05675
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    November 3, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 67-YEAR-OLD MAN UNDERWENT LHC, RHC AND IMPELLA CP PLACEMENT FOR ONGOING SUPPORT PENDING CABG WORK UP. THE PURGE LINE WAS DIVIDED INADVERTENTLY DURING PLACEMENT, AND THIS WAS REPLACED PER ADVICE FROM ABIOMED REP. ADDITIONALLY, DURING THE SECOND DAY OF IMPELLA CP SUPPORT, HEMATOMA AND OOZING FROM THE IMPELLA INSERTION SITE OCCURRED. HEPARIN HELD UNTIL ACT THERAPEUTIC, MANUAL PRESSURE AND REDRESSING AND ANGLE MATCHING OF SITE WAS PERFORMED. ADDITIONALLY, 1 UNIT OF BLOOD WAS GIVEN TO THE PATIENT AND SUPPORT CONTINUED AS PLANNED. PATIENT WAS TRANSFERRED TO OUTSIDE HOSPITAL AND RECEIVED FURTHER CARE INCLUDING IMPELLA 5.5 FOR POST OP SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702826 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026702525 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention