BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    MDR report key: 24662349 · Received March 23, 2026

    Report

    Report Number
    1220648-2026-05807
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    November 30, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    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

    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

    CLINICAL ASSESSMENT: 60 YEAR OLD FEMALE PATIENT WITH CARDIOGENIC SHOCK IMPLANTED WITH BOTH IMPELLA CP AND RP FLEX FOR BIVENTRICULAR SUPPORT. PATIENT CONTINUED TO DECOMPENSATE. VAGINAL BLEEDING OF UNKNOWN ORIGIN NOTED (PATIENT HAD OBGYN APPOINTMENT DAY PRIOR). PATIENT NOT IMPROVING AND HIGH PRESSURE ALARM NOTED ON RP FLEX PUMP. OFF LABEL TISSUE PLASMINOGEN ACTIVATOR (TPA) PROTOCOL ADMINISTERED IN THE PURGE. DESPITE EFFORTS FAMILY DECIDED TO WITHDRAW CARE. IMPELLA CP AND RP FLEX TO BE CODED TO MINOR BLEEDING AND DEATH, AND RP FLEX TO BE CODED TO MEDICATION CHANGE. ENGINEERING ASSESSMENT: DURING BIPELLA SUPPORT (BOTH RP AND CP SUPPORT) HIGH PURGE PRESSURE ALARMS OCCURRED ON THE RP FLEX PUMP. IT WAS NOTED THAT THERE WERE NO KINKS ON THE PUMP. IT WAS DECIDED TO EXCHANGE THE PURGE CASSETTE, AND THE ALARM RESOLVED. HOURS LATER, HIGH PURGE PRESSURE ALARM OCCURRED, AND PATIENT WAS GIVEN HEPARIN, ALARM CONTINUED, AND PATIENT WAS GIVEN TPA. THE DECISION WAS MADE TO WITHDRAW CARE. THE CP FUNCTIONED AS INTENDED FOR THE DURATION OF THE CASE. A PURGE CASSETTE EXCHANGE TEMPORARILY RESOLVED THE HIGH PURGE PRESSURE ALARMS FOR THE RP, AND THE HIGH PURGE PRESSURE CAN BE ATTRIBUTED TO AN ISSUE WITHIN THE PURGE SYSTEM, AS THE HIGH PURGE PRESSURE PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391410 PURGE CASSETTE GEN 2, STERILE, NON QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP DYB ABIOMED, INC. - 1220648 00813502012477

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female