BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 9766208 · Received February 27, 2020

    Report

    Report Number
    2523595-2020-00040
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 27, 2020
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION PUMP TUBING ORGANIZER (PTO) LEAK. SINCE THIS REPORTABLE MALFUNCTION IS ONLY ASSOCIATED WITH THE KIT, THIS MDR WILL ONLY BE AGAINST THE KIT. A BATCH RECORD REVIEW FOR KIT LOT H223 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCE'S ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT H223 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, PUMP TUBING ORGANIZER (PTO) LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THE ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. INVESTIGATION COMPLETE. MC: 001265. P.T. (B)(6) 2020.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A PUMP TUBING ORGANIZER (PTO) LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") AFTER AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT WAS ABORTED. THE CUSTOMER REPORTED THE ELECTRICITY ON THE HOSPITAL FLOOR WENT OUT DURING THE ECP TREATMENT. THE CUSTOMER ABORTED THE ECP TREATMENT AND DISCONNECTED THE PATIENT. THE CUSTOMER DID NOT RETURN RESIDUAL BLOOD WITHIN THE KIT TO THE PATIENT. THE CUSTOMER REPORTED THAT THEY "BROKE" THE KIT WHILE UNLOADING IT, WHICH RESULTED IN A BLOOD LEAK ON THE CELLEX INSTRUMENT'S PUMP DECK. THE CUSTOMER REPORTED THE PATIENT WAS IN GOOD CONDITION. THE CUSTOMER DISCARDED THE KIT AND WILL NOT BE RETURNING PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230567 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS, INC. NOT APPLICABLE H223

    Patients

    Seq Age Sex Outcome Treatment
    1