BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE, STERILE, NON-QSK

    MDR report key: 24532274 · Received March 6, 2026

    Report

    Report Number
    1220648-2026-04612
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FLUID LEAK: THE CAUSE OF THE FLUID LEAK WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED AND INSUFFICIENT CLINICAL DETAILS.

    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

    THE COMPLAINANT REPORTED A PURGE CASSETTE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92784 PURGE CASSETTE, STERILE, NON-QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PURGE CASSETTE, STERILE, NON-QSK

    Patients

    Seq Age Sex Outcome Treatment
    1