BEUDAMED
    FDA Adverse Event Death Summary report: N

    PURGE CASSETTE FINAL ASSY

    MDR report key: 24490172 · Received March 2, 2026

    Report

    Report Number
    1220648-2026-04362
    Event Type
    Death
    Date Received
    March 2, 2026
    Date of Event
    November 22, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEATH WAS UNRELATED TO THE IMPELLA AND INVOLVED A PATIENT IN SEVERE CARDIOGENIC SHOCK. CORRECTION. SECTION D4. WAS POPULATED WITH THE CONFIRMED SERIAL NUMBER OF THE DEVICE. NOTE: H6. COMPONENT AND INVESTIGATION TYPE/FINDINGS/CONCLUSION REMAIN UNCHANGED AS PREVIOUSLY REPORTED. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Additional Manufacturer Narrative · 0

    PATIENT-SPECIFIC INFORMATION (A4. WEIGHT, A5. ETHNICITY, AND A6. RACE) IS UNKNOWN AT THE TIME OF THIS MDR WRITING. PRODUCT-SPECIFIC INFORMATION (D4. UNIQUE DEVICE IDENTIFIER) IS UNKNOWN AT THE TIME OF THIS MDR WRITING AND RESPECTIVE FIELD HAS BEEN LEFT BLANK. MEDICAL SAFETY/CLINICAL REVIEW. MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. A 59-YEAR-OLD MALE IN CARDIOGENIC SHOCK (SCAI STAGE UNKNOWN) SECONDARY TO ACUTE MYOCARDIAL INFARCTION UNDERWENT IMPLANTATION OF AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. DURING THE PROCEDURE, LEAKAGE FROM THE PURGE CASSETTE WAS OBSERVED. THE PURGE CASSETTE WAS REPLACED WITH A NEW CASSETTE; HOWEVER, LEAKAGE WAS ALSO NOTED WITH THE REPLACEMENT CASSETTE. THE CUSTOMER REPORTED THAT THE PRESENCE OF AIR WITHIN THE SYSTEM MAY HAVE CONTRIBUTED TO THE OBSERVED FLUID LEAKAGE. DURING THE SAME EPISODE OF CARE, THE PATIENT EXPIRED WHILE ON IMPELLA SUPPORT. NO ADDITIONAL CLINICAL DETAILS WERE PROVIDED REGARDING THE CIRCUMSTANCES OF DEATH. BASED ON THE LIMITED INFORMATION AVAILABLE, THE IMPELLA CASSETTES ARE BEING CONSERVATIVELY REPORTED AS A DEATH TYPE OF REPORTABLE EVENT. WHILE THERE IS NO CONFIRMED EVIDENCE OF THIS DEVICE MALFUNCTION DIRECTLY CAUSING THE DEMISE OUTCOME, POTENTIAL COMPROMISE TO PURGE SYSTEM INTEGRITY AND DEVICE SUPPORT CANNOT BE FULLY EXCLUDED DUE TO INCOMPLETE INFORMATION. INVESTIGATION SUMMARY. THE DEVICE WAS RECEIVED AND EVALUATED. PURGE LEAK - CASSETTE: THE CAUSE OF THE REPORTED PURGE CASSETTE LEAK WAS NOT ESTABLISHED DUE TO ISSUE NOT REPRODUCED IN INVESTIGATION LAB. PRIMING PROBLEM: THE CAUSE OF PRIMING PROBLEM WAS NOT ESTABLISHED DUE TO INSUFFICIENT CLINICAL DETAILS AND ISSUE NOT REPRODUCED DURING EVALUATION. NO DATA LOGS WERE RETURNED. DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND THE CASSETTE PASSED ALL THE REQUIRED INSPECTION TESTS. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Description of Event or Problem · 0

    A 59-YEAR-OLD MALE IN CARDIOGENIC SHOCK (SCAI STAGE UNKNOWN) SECONDARY TO ACUTE MYOCARDIAL INFARCTION UNDERWENT IMPLANTATION OF AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. DURING THE PROCEDURE, LEAKAGE FROM THE PURGE CASSETTE WAS OBSERVED. THE PURGE CASSETTE WAS REPLACED WITH A NEW CASSETTE; HOWEVER, LEAKAGE WAS ALSO NOTED WITH THE REPLACEMENT CASSETTE. THE CUSTOMER REPORTED THAT THE PRESENCE OF AIR WITHIN THE SYSTEM MAY HAVE CONTRIBUTED TO THE OBSERVED FLUID LEAKAGE. DURING THE SAME EPISODE OF CARE, THE PATIENT EXPIRED WHILE ON IMPELLA SUPPORT. NO ADDITIONAL CLINICAL DETAILS WERE PROVIDED REGARDING THE CIRCUMSTANCES OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287029 PURGE CASSETTE FINAL ASSY TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 1910074

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death