BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21288821 · Received January 31, 2025

    Report

    Report Number
    1220648-2025-25946
    Event Type
    Death
    Date Received
    January 31, 2025
    Date of Event
    January 19, 2025
    Report Date
    March 5, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B1 REVISED TO REFLECT BOTH ADVERSE EVENT AND PRODUCT PROBLEM ON MANUFACTURER DEVICE REPORT 1220648-2025-25946. B2 REVISED TO REFLECT DEATH, THE EXACT DATE OF DEATH IS UNKNOWN 1220648-2025-25946. B5 REVISED TO INCLUDE PATIENT OUTCOME AND MSO STATEMENT WHICH INADVERTENTLY WAS NOT INCLUDED ON MANUFACTURER DEVICE REPORT 1220648-2025-25946-1. E4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25946 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. G1 MANUFACTURING SITE NAME AND ADDRESS REVISED AS WAS INADVERTENTLY REPORTED INCORRECTLY ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25946-1. H1 TYPE OF REPORT REVISED TO REFLECT THE PATIENT OUTCOME OF DEATH ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25946. H6 REVISED TO REFLECT THE PATIENT OUTCOME OF DEATH ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25946.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D9, H3, H6 AND H10. THE INVESTIGATION INTO THE REPORTED ISSUE HAS BEEN COMPLETED. CONSOLE LOGS DID NOT CONTAIN ANY DATA RELEVANT TO THIS COMPLAINT. THE CONSOLE WAS EVALUATED, AND THE REPORTED BROKEN PURGE DISC RETAINER WAS CONFIRMED. THE ROOT CAUSE OF THIS ISSUE WAS A BROKEN PURGE DISC RETAINER. BEFORE SENDING THIS CONSOLE BACK TO THE CUSTOMER, FIELD SERVICE WAS INSTRUCTED TO PERFORM THE FOLLOWING: REPLACE THE BLUE PURGE DISC RETAINER, PURGE DISC DETECT FLAG, AND PURGE FLAG SPRING, PERFORM PREVENTATIVE MAINTENANCE AND ALL FUNCTIONAL CHECKS ON THE CONSOLE AND OPTICAL SYSTEM.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    AFTER 69.48 HOURS OF SUPPORT THE DECISION WAS MADE BY THE FAMILY TO WITHDRAW CARE PLACE PATIENT ON PALLIATIVE CARE AND THE PATIENT EXPIRED. THE EXACT DATE OF DEATH IS UNKNOWN. PER THE MEDICAL SAFETY OFFICER REVIEW IT IS UNKNOWN IF THE USE OF THE IMPELLA WAS RELATED TO PATIENT DEATH, THUS THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING PURGE CASSETTE REPLACEMENT, THE DISC HOLDER ON THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS INADVERTENTLY TORN OFF. THE AIC WAS REPLACED TO RESOLVE THE DAMAGE. THERE WAS NO PATIENT HARM AND SUPPORT CONTINUED WITH THE IMPLANTED PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088473 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1275229 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death