BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP FLEX

    MDR report key: 21911831 · Received April 25, 2025

    Report

    Report Number
    1220648-2025-27862
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    April 4, 2025
    Report Date
    May 27, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF HEMOLYSIS AND ACCESS SITE BLEEDING HAS BEEN COMPLETED. THE DATA LOGS SHOWED PUMP RAN WITHOUT ISSUE DURING SUPPORT. PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION FOUND NO ISSUES ON THE PUMP. PUMP WAS CONDUCTED HEMOLYSIS TEST AND PASSED THE TEST. THE ROOT CAUSE OF ACCESS SITE BLEEDING WAS MOST LIKELY ANTICOAGULATION MANAGEMENT RELATED SINCE ACTIVATED CLOTTING TIME (ACT) WAS HIGH WHEN THE BLEEDING OCCURRED AND NO ISSUE WAS FOUND ON THE PUMP UNDER PRODUCT ANALYSIS. THE ROOT CAUSE OF HEMOLYSIS WAS MOST LIKELY PATIENT CONDITION RELATED SINCE NO ISSUE WAS FOUND ON THE PUMP UNDER PRODUCT ANALYSIS AND THE PATIENT HAD RENAL INSUFFICIENCY AND ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) BEFORE PLACING IMPELLA. PUMP POSITION WAS GOOD.

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA RP FLEX WITH SMARTASSIST INSTRUCTIONS FOR USE & CLINICAL REFERENCE MANUAL SECTION: USING THE AUTOMATED IMPELLA CONTROLLER WITH THE IMPELLA RP FLEX SMARTASSIST SYSTEM CATHETER USE OF THE REPOSITIONING SHEATH AND THE 23 FR PEEL-AWAY INTRODUCER ¿MAKE SURE THERE IS NO BLEEDING AT THE TRANSITION FROM THE REPOSITIONING SHEATH TO THE INTERNAL JUGULAR VEIN. CLOSE AND DRESS THE WOUND .¿

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AFTER IMPELLA RP FLEX WAS PLACED. THE PATIENT WAS RESTLESS AND BLEEDING WAS OBSERVED AT THE IMPELLA ACCESS SITE. MANUAL COMPRESSION AND HEMOSTATIC SUTURE WERE DONE. IT WAS FURTHER REPORTED THAT HEMOLYSIS WAS OBSERVED AS LABS WERE HEMOLYZED. THE IMPELLA RP FLEX WAS CONFIRMED TO BE IN GOOD POSITION. THE IMPELLA RP FLEX P-LEVEL WAS DROPPED AND THE TEAM WILL BE MONITORING THE HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346189 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2026625112 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention