BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    MDR report key: 24438435 · Received February 24, 2026

    Report

    Report Number
    1220648-2026-03962
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    February 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3 (MANUFACTURER FAX) HAS BEEN ADDED. D6A (IMPLANTATION) AND D6B (EXPLANTATION) DATES HAS BEEN ADDED. E4 (REPORTER ALSO SENT REPORT TO FDA?) HAS UPDATED TO UNKNOWN. G1 (MANUFACTURER CONTACT FAX NUMBER) HAS BEEN ADDED AS THIS WAS BEEN OMITTED FROM THE INITIAL MW. PURGE PRESSURE LOW: THE CAUSE OF PURGE PRESSURE LOW WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW.

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. 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 THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. BEFORE INITIATION OF MECHANICAL CIRCULATORY SUPPORT, THE IMPELLA PURGE SYSTEM ¿OPEN¿ ALARM WAS NOTED TO BE ACTIVE. THE PURGE CASSETTE WAS EXCHANGED, AFTER WHICH THE ALARM RESOLVED AND THE SYSTEM FUNCTIONED APPROPRIATELY WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498947 PURGE CASSETTE GEN 2, STERILE, NON QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2031851 00813502012477

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female