BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 22115622 · Received May 30, 2025

    Report

    Report Number
    22115622
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 12, 2025
    Report Date
    May 13, 2025
    Manufacturer
    THERAKOS LLC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WAS PRIMING ECP [EXTERNAL COUNTERPULSATION] MACHINE WITH A KIT # N344 WHEN THE BOWL SHATTERED. MACHINE AND INCIDENT CALLED IN TO THERAKOS, MACHINE TAKEN OUT OF SERVICE. VENDOR SAID THERE ARE NO RECALLS ON THIS ITEM, BUT THEY HAVE OTHER CUSTOMERS EXPERIENCING THE SAME. THERAKOS RESPONDED TO OUR SITE WITH A MFG [MANUFACTURER] LETTER REINFORCING THE PRIMING TECHNIQUE FOR LOADING THE BOWL TO PREVENT SHATTERING. THE STAFF CONFIRM THIS WAS NOT USER ERROR AND WAS LOADED ACCORDING TO THE MFG INSTRUCTIONS. MANUFACTURER RESPONSE FOR BOWL IN PHOTOPHERESIS KIT, THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM (CELLEX) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27497 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS LLC. CLXUSA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown