BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24118838 · Received January 20, 2026

    Report

    Report Number
    1220648-2026-01154
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    January 9, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    THE INVESTIGATION WAS COMPLETED AND NO DEVICE WAS RETURNED. INVESTIGATION SUMMARY: ASAE/HEMATOMA: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS PATIENT RELATED DUE TO THE PATIENT¿S COAGULOPATHY.

    Additional Manufacturer Narrative · 0

    B5 ADDITIONAL INFORMATION WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT. H6 HEALTH EFFECT - CLINICAL CODE E0303 (HEMOLYSIS), MEDICAL DEVICE PROBLEM CODE A01 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT H6 HEALTH EFFECT - IMPACT CODE F19 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Description of Event or Problem · 0

    A 64-YEAR-OLD MALE PATIENT UNDERWENT POST-OPERATIVE HEART TRANSPLANT SURGERY AND WAS SUPPORTED WITH AN RP FLEX PUMP ((B)(4), GU CASE (B)(4), SN (B)(6)) IMPLANTED ON (B)(6) 2026 AT 17:53 AND EXPLANTED ON (B)(6) 2026 AT 12:30. THE RP FLEX DEVICE PROVIDED CIRCULATORY SUPPORT DURING THE IMMEDIATE POST-OPERATIVE PERIOD FOLLOWING HEART TRANSPLANT WITHOUT REPORTED ALARMS OR PLACEMENT ISSUES. THE OBSERVED COMPLICATIONS¿HEMOLYSIS AND HEMATOMA¿OCCURRED IN THE CONTEXT OF SYSTEMIC ANTICOAGULATION AND ACTIVE COAGULOPATHY, WHICH ARE COMMON RISK FACTORS IN POST-TRANSPLANT PATIENTS. BASED ON AVAILABLE INFORMATION, THE RP FLEX FUNCTIONED AS INTENDED. THE EVENTS OF HEMOLYSIS AND HEMATOMA ARE CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT SURVIVED EXPLANT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE RED TINGED URINE WAS RELATED TO HYDROXOCOBALAMIN GIVEN FOR VASOPLEGIA, THE RED TINGED URINE WAS RELATED TO THAT AND NOT HEMOLYSIS PER BEDSIDE NURSE. INSERTION SITE WAS REDRESSED AND SUTURES ADJUSTED IN RESPONSE TO HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262721 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026675509 813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other