BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24189714 · Received January 27, 2026

    Report

    Report Number
    1220648-2026-01576
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    October 8, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPELLA RP FLEX SN (B)(6) + USB RETURNED FOR EVALUATION. THE RETURNED USB WAS BLANK, FIELD DATA LOGS NOT AVAILABLE. ARRYTHMIA: IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. LOW/BLOCKED FLOW: ON DAY 13 OF SUPPORT THE PUMP WAS NOT TURNED DOWN FOR PERMACATH PLACEMENT AND AFTER PLACEMENT THE RP FLOWS DROPPED TO 0.2 AT P-5. BIOMATERIAL WAS OBSERVED; ACT WAS MAINTAINED THROUGHOUT SUPPORT. RETURNED PRODUCT SHOWED BIOMATERIAL AROUND THE IMPELLER. THERE WAS A SIGNIFICANT CANNULA KINK DISTAL TO THE MOTOR HOUSING AND ANOTHER KINK BY THE KINK PROTECTOR. WITHOUT FIELD DATA LOGS, THE ISSUE CANNOT BE INVESTIGATED FURTHER TO DETERMINE WHETHER THE BIOMATERIAL OR CANNULA KINK CAUSED THE LOW FLOW DURING THE CASE. THE CAUSE OF THE LOW FLOW WAS UNABLE TO BE DETERMINED DUE TO NO FIELD DATA LOGS RETURNED. PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE PATIENT HAD ONGOING ATRIAL FIBRILLATION, AND THE CRITICAL CARE TEAM PLANNED TO INTUBATE THE PATIENT DUE TO INCREASED WORK OF BREATHING WHILE ON NONINVASIVE VENTILATION, FOLLOWED BY CARDIOVERSION AND INITIATION OF CONTINUOUS RENAL REPLACEMENT THERAPY. THE FIRST PUMP, AN RP FLEX DEVICE, WAS IN USE AND WAS LATER REPLACED WITH A SECOND RP FLEX PUMP. ADDITIONAL INFORMATION STATES THAT THE INITIAL PUMP WAS ASSOCIATED WITH CONCERNS THAT INCLUDED ATRIAL FIBRILLATION, CARDIOVERSION, THE NEED FOR CONTINUOUS RENAL REPLACEMENT THERAPY, POSSIBLE EVALUATION FOR HEMOLYSIS OR RENAL INVOLVEMENT, LOW FLOWS, AND THE NEED FOR PUMP REVISION OR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251812 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 RP FLEX W SMART ASSIST SET, US 2026709799 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention