BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24463004 · Received February 26, 2026

    Report

    Report Number
    1220648-2026-04167
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    December 3, 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
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    D1: CORRECTED DEVICE NAME. D4: CORRECTED DEVICE CATALOG NUMBER, LOT NUMBER, AND UDI NUMBER, EXPIRATION DATE. D9: UPDATED DEVICES RETURN INFORMATION. H4: CORRECTED MANUFACTURER DATE.

    Description of Event or Problem · 0

    AN 84-YEAR-OLD MALE WITH A HISTORY OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK WAS INITIALLY TREATED WITH INOTROPES, VASOPRESSORS, AND AN INTRA-AORTIC BALLOON PUMP FOR LEFT-SIDED MECHANICAL CIRCULATORY SUPPORT. DUE TO PERSISTENT HEMODYNAMIC INSTABILITY AND EVIDENCE OF RIGHT VENTRICULAR DYSFUNCTION, THE HEART TEAM ELECTED TO IMPLANT AN IMPELLA RP FLEX FOR RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT. FOLLOWING IMPLANTATION, THE PATIENT¿S PULMONARY ARTERY PULSATILITY INDEX (PAPI) IMPROVED FROM 0.4 TO 1.1, INDICATING IMPROVED RIGHT VENTRICULAR PERFORMANCE WITH IMPELLA RP FLEX SUPPORT. APPROXIMATELY ONE HOUR AFTER PLACEMENT OF A CENTRAL LINE FOR CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT), THE AUTOMATED IMPELLA CONTROLLER DISPLAYED A PLACEMENT SIGNAL NOT RELIABLE (PSNR) ALARM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DESPITE THE ALARM. THE CLINICAL TEAM UTILIZED ALTERNATIVE APPROVED HEMODYNAMIC MONITORING DEVICES TO ASSESS AND GUIDE MANAGEMENT. NO INTERRUPTION IN IMPELLA SUPPORT WAS REPORTED. THE FOLLOWING DAY, THE CLINICAL TEAM DEVELOPED CONCERN FOR POSSIBLE SEPSIS BASED ON EVOLVING CLINICAL INDICATORS AND OBTAINED BLOOD CULTURES. OVER THE SUBSEQUENT DAYS: THE PATIENT TOLERATED WEANING OF INOTROPES AND VASOPRESSORS. HE RECEIVED 1 UNIT OF PACKED RED BLOOD CELLS FOR ANEMIA, WHICH WAS SUSPECTED TO BE RELATED TO HEMOLYSIS. IMPELLA RP FLEX SUPPORT CONTINUED TO PROVIDE HEMODYNAMIC STABILITY DURING ONGOING MANAGEMENT. AFTER 10 DAYS OF IMPELLA RP FLEX SUPPORT, THE DEVICE WAS: SUCCESSFULLY WEANED, AND REMOVED WITHOUT COMPLICATION. DURING RP FLEX SUPPORT, THE PLACEMENT SIGNAL UNRELIABLE ALARM BECAME ACTIVE. A CLINICAL SUPPORT CALL WAS MADE AND THE RN WAS WALKED THROUGH HOW TO DISABLE THE ALARM AUDIO. NO CHANGE IN PT HEMODYNAMICS. IT WAS LATER NOTED IN THE COMPLAINT THAT THE CARE TEAM SUSPECTED HEMOLYSIS WITH HG 7.2 AND GAVE BLOOD TO THE PATIENT. OVERALL, THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526466 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 IMPELLA PUMP, RP-IJ, STERILE 2026679965 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention