BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    MDR report key: 24630683 · Received March 18, 2026

    Report

    Report Number
    1220648-2026-05583
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    November 29, 2025
    Report Date
    May 5, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012477
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D4 CATALOG NUMBER UPDATED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 62 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY OF DIABETES, HYPERTONUS, HYPERLIPIDEMA, RENAL INSUFFICIENCE, CORONARY ARTERY DISEASE, HEART FAILURE AND TREATED WITH AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR PRESENTED WITH WORSENING HEART FAILURE ON MILRINONE AND WAS CONSIDERED FOR POSSIBLE DURABLE LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION OR HEART TRANSPLANTATION. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR PLACEMENT OF AN IMPELLA 5.5. DURING PREPARATION OF THE DEVICE, AN ¿OPTICAL SENSOR SYSTEM ERROR ¿ OCCURRED. BOTH THE CONSOLE AND THE DEVICE WERE EXCHANGED. AFTER A FULL SYSTEM CHANGE, THE NEW DEVICE WAS SUCCESSFULLY INSERTED WITHOUT ISSUES AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT FOR FURTHER SUPPORT. FOLLOWING A MONTH OF SUPPORT, A PURGE FLUID LEAK WAS DETECTED AND THE PURGE CASSETTE WAS EXCHANGED. THE PATIENT CONTINUED TO BE SUPPORTED IN AN OFF-LABEL PROLONGED DURATION OF SUPPORT WITH UNKNOWN OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325865 PURGE CASSETTE GEN 2, STERILE, NON QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1981979 00813502012477

    Patients

    Seq Age Sex Outcome Treatment
    1