BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24662229 · Received March 23, 2026

    Report

    Report Number
    1220648-2026-05806
    Event Type
    Death
    Date Received
    March 23, 2026
    Date of Event
    November 30, 2025
    Report Date
    May 11, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    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 UDI NUMBER UPDATED.

    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.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D4 SERIAL NUMBER UPDATED.

    Description of Event or Problem · 0

    A 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 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. 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
    588332 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026640612

    Patients

    Seq Age Sex Outcome Treatment
    1