BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 21224531 · Received January 23, 2025

    Report

    Report Number
    1220648-2025-25755
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    January 9, 2025
    Report Date
    February 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE OPTICAL SIGNAL ISSUE AND LOW PUMP FLOW HAS BEEN COMPLETED. THE PUMP WAS NOT RETURNED FOR INVESTIGATION. THE DATA LOG SHOWS THAT THE PLACEMENT SIGNAL WAS AN UNRELIABLE ALARM, WITH A VALUE OF 3000 FROM THE PUMP PLUGGED INTO THE CONSOLE. ADDITIONALLY, THE PUMP WAS STARRED, AND THE IMPELLA FLOW SHOWED 0 L/MIN. ALL 5S OPTICAL SIGNAL VALUES WERE WITHIN SPECIFICATIONS. THE IMC LOG CONFIRMS THE SUSPICIOUS CALIBRATION VALUES DURING STARTUP. OPTICAL SIGNAL ISSUE MIGHT BE RELATED TO AN AIC SOFTWARE ISSUE, AND IT WILL BE INVESTIGATED IN 25-4068-2. THE CAUSE OF THE LOW PUMP FLOW ISSUE WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED. THE CAUSE OF THE OPTICAL SIGNAL ISSUE WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED.

    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.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA CP SUPPORT AND AFTER THE IMPLANT, AORTIC WAVEFORM WAS NOT PRESENT. THERE WAS ALSO A PLACEMENT SIGNAL UNRELIABLE ALARM. THE PUMP STARTED ON AUTO AND THE FLOW TILE STATED IMPELLA FLOW CALCULATION DISABLED THEN READ 0/0 WITH A MOTOR CURRENT PEAKING AT 962/626 (628). THE PUMP WAS EXPLANTED AND REPLACED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668247 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025578925 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male