BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    MDR report key: 24816026 · Received April 8, 2026

    Report

    Report Number
    1220648-2026-06502
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    April 1, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012477
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D9. CORRECTED INFORMATION HAS BEEN PROVIDED IN H3. PRIMING PROBLEM: THE CAUSE OF PRIMING PROBLEM WAS NOT DETERMINED SINCE THE ISSUE NOT REPRODUCED DURING EVALUATION.

    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

    CLINICAL NARRATIVE; AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 67 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE, WITH A PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). UNDERLYING MEDICAL HISTORY WAS NOT SHARED. AS THE TEAM WAS SETTING UP FOR THE SUPPORT AND PCI THE PURGE CASSETTE FAILED TO PRIME AS EXPECTED. MULTIPLE ATTEMPTS WERE MADE, BUT THEY FOUND THEY NEEDED TO REPLACE THE CASSETTE. THE PRIMING FAILURE LEAD TO THE EXCHANGE, HOWEVER THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT. THE PUMP SUPPORTED FOR THE PCI AND WAS THEN WEANED AND EXPLANTED. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283867 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2010651 00813502012477

    Patients

    Seq Age Sex Outcome Treatment
    1