BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP EU

    MDR report key: 18326174 · Received December 14, 2023

    Report

    Report Number
    1220648-2023-05393
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    December 14, 2022
    Report Date
    February 28, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE REPORTED HIGH PURGE PRESSURE HAS BEEN COMPLETED SINCE THE ORIGINAL REPORT WAS FILED. PUMP AND DATA LOGS WERE NOT AVAILABLE FOR REVIEW. AS PER THE CLINICAL REVIEW, AIR IN PURGE ALARM WAS REPORTED DURING PUMP USE. THE CAUSE OF THE PRIMING ISSUE WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED AND SUFFICIENT CLINICAL INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: ¿MAINTAINING ACT AT OR ABOVE 250 SECONDS WILL HELP PREVENT A THROMBUS FROM ENTERING THE CATHETER AND CAUSING A SUDDEN STOP ON STARTUP.¿ ¿UNRESOLVED PURGE PRESSURE HIGH ALARM IF NOT RESOLVED BY THE RECOMMENDATIONS PROVIDED, HIGH PURGE PRESSURE WHICH TRIGGERS THE ¿PURGE PRESSURE HIGH¿ ALARM MESSAGE COULD BE AN INDICATION OF A KINK IN THE IMPELLA CATHETER. IN THIS CASE, THE MOTOR IS NO LONGER BEING PURGED AND MAY EVENTUALLY STOP.¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 63-YEAR-OLD MALE NOTED AS HIGH RISK CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT HAD AN AIR IN PURGE SYSTEM ALARM WHILE BEING MOVED FROM THE CATH LAB TO ICU. THE ISSUE DID NOT RESOLVE EVEN AFTER VENTING MULTIPLE TIMES. UPON ARRIVAL TO THE ICU, THE P-LEVEL WAS STILL ON AUTO MC AT 1107/906 MA AND AN EMERGENCY SHUTDOWN WAS IMMINENT. THE IMPELLA HAD TO BE RESTARTED TWICE, AFTER WHICH THE PURGE FLOW AND PRESSURE IMPROVED AND THE MC VALUES NORMALIZED. THE IMPELLA WAS SCHEDULED FOR REMOVAL THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326373 IMPELLA CP EU TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP EU 2023275286 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male