BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

    MDR report key: 19651695 · Received July 1, 2024

    Report

    Report Number
    3013428851-2024-00060
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 15, 2024
    Report Date
    July 1, 2024
    Manufacturer
    MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS AN MDR DUE TO THE MEDICAL INTERVENTION OF THE SUPPLEMENTAL OXYGEN AND IV FLUIDS THAT WERE PROVIDED TO THE PATIENT. SINCE THIS EVENT IS ASSOCIATED WITH THE TREATMENT, THIS MDR WILL BE AGAINST THE INSTRUMENT. FROM THE INSTRUMENT PERSPECTIVE, THERE WAS NO KNOWN INSTRUMENT MALFUNCTION AND NO SERVICE WAS REQUESTED BY THE CUSTOMER FOR THIS ADVERSE EVENT. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE CELLEX INSTRUMENT'S SERIAL NUMBER WAS NOT PROVIDED WITHIN THE COMPLAINT THUS A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. THE CUSTOMER REPORTED THAT THEY BELIEVED THAT THE PATIENT'S DYSPNEA, OXYGEN DESATURATION, AND HYPOTENSION WERE RELATED TO THE PATIENT'S ECP TREATMENT PROCEDURE. HOWEVER, THE ROOT CAUSE FOR THE PATIENT'S DYSPNEA, OXYGEN DESATURATION, AND HYPOTENSION COULD NOT BE DETERMINED AS THERE WAS NO REPORTED INSTRUMENT ISSUE, NO PRODUCT WAS RETURNED FOR INVESTIGATION, AND NO INSTRUMENT SERVICE WAS REQUESTED BY THE CUSTOMER OR PERFORMED BY THERAKOS AS A RESULT OF THIS INCIDENT. IN ADDITION, AN EKG AND CT SCAN WERE PERFORMED, AND THEY WERE BOTH NEGATIVE FOR ANY ISCHEMIA OR PULMONARY EMBOLISM. PER THE CELLEX OPERATOR'S MANUAL SECTION 2-3 ADVERSE EVENTS, HYPOTENSION MAY OCCUR DURING ANY TREATMENT INVOLVING EXTRACORPOREAL CIRCULATION. CLOSELY MONITOR THE PATIENT DURING THE ENTIRE TREATMENT FOR HYPOTENSION. IN ADDITION, PER THE CELLEX OPERATOR'S MANUAL SECTION 2-4 ADVERSE REACTIONS, SIDE EFFECTS OF PHOTOPHERESIS (UVADEX® USED WITH CELLEX® SYSTEMS) WERE PRIMARILY RELATED TO HYPOTENSION SECONDARY TO CHANGES IN EXTRACORPOREAL VOLUME (>1%). TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, DYSPNEA, OXYGEN DESATURATION, AND HYPOTENSION. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. ADVERSE EVENT TERMS: DYSPNEA, LOW OXYGEN SATURATION, AND LOW BLOOD PRESSURE/HYPOTENSION. (B)(4). (B)(6) 2024.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED DYSPNEA, OXYGEN DESATURATION, AND HYPOTENSION DURING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT EXPERIENCED DYSPNEA WITHIN TEN MINUTES OF STARTING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT'S PULSE OX AND BLOOD PRESSURE ALSO DROPPED SO THEY ADMINISTERED SUPPLEMENTAL OXYGEN AND IV FLUIDS TO THE PATIENT. THE CUSTOMER STATED THAT THEY ENDED THE PATIENT'S ECP TREATMENT PROCEDURE WITH BLOOD RETURNED, AND THE PATIENT'S CONDITION IMPROVED. THE CUSTOMER REPORTED THAT THEY PERFORMED AN EKG AND CT SCAN, AND BOTH WERE NEGATIVE FOR ANY ISCHEMIA OR PULMONARY EMBOLISM. THE CUSTOMER STATED THAT THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THE CUSTOMER REPORTED THAT THEY BELIEVED THAT THE PATIENT'S DYSPNEA, OXYGEN DESATURATION, AND HYPOTENSION WERE RELATED TO THE PATIENT'S ECP TREATMENT PROCEDURE. THE CUSTOMER WAS UNABLE TO PROVIDE THE CELLEX INSTRUMENT'S SERIAL NUMBER. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571872 CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM, LNR MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention