BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE, STERILE, NON-QSK

    MDR report key: 24451005 · Received February 26, 2026

    Report

    Report Number
    1220648-2026-04068
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    October 8, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT-SPECIFIC INFORMATION: A4. WEIGHT AND A5. ETHNICITY, IS UNKNOWN. MEDICAL SAFETY REVIEW. MEDICAL SAFETY REVIEW WAS COMPLETED AND NOTED THE FOLLOWING: UPON PREPPING AN IMPELLA CP DEVICE THERE WAS NOTED TO BE A LEAK IN THE PURGE CASSETTE WITH AN AIR IN LINE ALARM. THE CASSETTE WAS REPLACED AND SET UP AND INSERTION CONTINUED WITHOUT ISSUE. IMPELLA CP WAS PLACED AFTER CARDIOPULMONARY RESUSCITATION WAS INITIALED AND RESUSCITATION CONTINUED THROUGHOUT INSERTION POST INTERVENTION THE PATIENT WENT TO THE INTENSIVE CARE UNIT (ICU) WHERE THEY EXPIRED 3 HOURS LATER. DUE TO THE LEAK IN THE PURGE CASSETTE THIS IS A DEVICE MALFUNCTION ON THE PURGE CASSETTE. BECAUSE THE IMPELLA CP WAS IN PLACE WHEN THE PATIENT PASSED AWAY IT IS BEING CONSERVATIVELY REPORTED HOWEVER IS VERY UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT OUTCOME AND THE DEATH IS LIKELY THE RESULT OF THE PATIENT'S CLINICAL PRESENTATION. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA CASSETTE DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA CP, WHICH IS ASSOCIATED WITH THE DEMISE OUTCOME. 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

    IT WAS REPORTED DURING PREPPING AN IMPELLA CP DEVICE, THERE WAS NOTED TO BE A LEAK IN THE PURGE CASSETTE WITH AN AIR IN LINE ALARM. THE CASSETTE WAS REPLACED AND SET UP CONTINUED WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514518 PURGE CASSETTE, STERILE, NON-QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female