BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

    MDR report key: 22484598 · Received July 11, 2025

    Report

    Report Number
    3013428851-2025-00096
    Event Type
    Injury
    Date Received
    July 11, 2025
    Report Date
    July 11, 2025
    Manufacturer
    MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS AN MDR AS THE PATIENT'S RESPIRATORY FAILURE DUE TO AN AIR EMBOLISM IS CONSIDERED LIFE-THREATENING AND ALSO DUE TO THE MEDICAL INTERVENTION THAT WAS 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 AUTHOR FOR THIS ADVERSE EVENT. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE CELLEX INSTRUMENT'S SERIAL NUMBER WAS NOT PROVIDED WITHIN THE ABSTRACT THUS A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. THE ROOT CAUSE FOR THE PATIENTS' RESPIRATORY FAILURE, AIR EMBOLISM, AND CENTRAL LINE INFECTIONS 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 AUTHOR OR PERFORMED BY THERAKOS AS A RESULT OF THIS INCIDENT. THE AUTHOR STATED THAT THE SEVEN CASES OF CENTRAL LINE INFECTIONS WERE NOT CONSIDERED SERIOUS. THE AUTHOR WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION CONCERNING THESE EVENTS. IN THE CELLEX INSTRUMENT DIGITAL ULTRASONIC PULSES ARE USED TO DETECT AIR BUBBLES IN THE PATIENT COLLECT AND RETURN LINES AS WELL AS THE ANTICOAGULANT LINE. AN ALARM CONDITION OCCURS ANY TIME AIR IS DETECTED IN THESE LINES DURING A TREATMENT. ADDITIONAL AIR DETECTORS ARE USED TO MONITOR THE LEVEL OF FLUID IN THE RETURN BAG AND TREATMENT BAG. ALL AIR DETECTORS ARE TESTED AS PART OF THE INSTRUMENT POWER-ON SELF-TEST. THE FOLLOWING SECTIONS OF THE CELLEX OPERATOR MANUAL ALSO PROVIDE CAUTIONS AND WARNINGS IN REGARDS TO AIR WITHIN THE SYSTEM. SECTION 5.4 CAUTION: IF HEMOLYSIS OR UNEXPECTED AIR IS OBSERVED DURING A PHOTOPHERESIS TREATMENT, THE THERAPY MUST BE ABORTED AND BLOOD SHOULD NOT BE RETURNED TO THE PATIENT. SECTION 5-5 CAUTION: WHEN INSTRUCTED, ESTABLISH OR DISCONNECT PATIENT ACCESS IN ACCORDANCE WITH YOUR INSTITUTION'S STANDARDS OF PRACTICE FOR THIS PROCEDURE. FAILURE TO DO SO MAY LEAD TO PATIENT HARM SUCH AS INCREASED RISK OF INFECTION, TRAUMA TO THE ACCESS SITE, POSSIBLE AIR EMBOLUS OR POST TREATMENT BLOOD LOSS. SECTION 5-13 WARNING: DO NOT CONNECT PATIENT TO THE PROCEDURAL KIT LINES PRIOR TO COMPLETING PRIME ACCESS. PRESSING PRIME TO COMPLETE PRIME ACCESS WITH PATIENT CONNECTED WILL CAUSE AIR IN THE LINE TO BE DELIVERED TO THE PATIENT. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, INFECTION, AIR EMBOLISM, AND RESPIRATORY FAILURE. 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: UNSPECIFIED INFECTION, AIR EMBOLISM AND RESPIRATORY FAILURE COMP-067710 S.K. (B)(6) 2025.

    Description of Event or Problem · 0

    IN AN ABSTRACT ENTITLED EXTRACORPOREAL PHOTOPHERESIS TREATMENT IN PEDIATRIC PATIENTS WITH GVHD: INSIGHTS FROM A CASE SERIES BY PONS ET AL., PRESENTED AT THE EUROPEAN BONE MARROW TRANSPLANT 51ST ANNUAL MEETING ON 30 MARCH-02 APRIL 2025, THE AUTHORS STATED THAT EXTRACORPOREAL PHOTOPHERESIS (ECP) IS A TREATMENT OPTION FOR BOTH ACUTE AND CHRONIC GRAFT VERSUS HOST DISEASE (GVHD) DUE TO ITS IMMUNOMODULATORY EFFECTS. WHILE NUMEROUS STUDIES HAVE EVALUATED THE USE OF ECP IN VARIOUS PATIENT SETTINGS, MOST FOCUSED ON A SMALL NUMBER OF PATIENTS, PARTICULARLY IN THE PEDIATRIC POPULATION, HIGHLIGHTING A GAP IN UNDERSTANDING THE USE OF ECP IN CHILDREN. THE AUTHORS PERFORMED A RETROSPECTIVE STUDY IN A SINGLE PEDIATRIC CENTER FROM 2019 TO 2024. ALL CONSECUTIVE PATIENTS TREATED WITH THE THERAKOS CELLEX PHOTOPHERESIS SYSTEM WERE INCLUDED IN THEIR RETROSPECTIVE STUDY. THE AUTHORS REPORTED THAT THE PATIENTS FIRST RECEIVED TWO ECP SESSIONS PER WEEK, THEN EVERY TWO WEEKS, WITH TREATMENT DURATION VARYING ACCORDING TO PATIENT RESPONSE. GVHD SEVERITY WAS GRADED ACCORDING TO THE MOUNT SINAI ACUTE GVHD INTERNATIONAL CONSORTIUM (MAGIC) SYSTEM OR THE NATIONAL INSTITUTE OF HEALTH (NIH) SYSTEM FOR CHRONIC GVHD. THE AUTHORS STATED THAT THEIR STUDY INCLUDED TWENTY-SEVEN PATIENTS BETWEEN THE AGES OF TEN MONTHS AND SEVENTEEN YEARS, OF WHOM 26.9% WERE YOUNGER THAN FIVE YEARS. THE PATIENTS HAD PREVIOUSLY RECEIVED A HAEMATOPOIETIC STEM CELL TRANSPLANT FROM EITHER AN UNRELATED (69.2%) OR A HAPLOIDENTICAL DONOR (27%), WHILE ONLY ONE PATIENT HAD RECEIVED A MATCHED SIBLING DONATION (3.8%). THE AUTHORS STATED THAT ECP WAS USED AS EITHER A SECOND- OR THIRD-LINE TREATMENT IN 81.5% OF CASES AND BEYOND THE FOURTH LINE TREATMENT IN THE REMAINING PATIENTS. THE AUTHORS REPORTED THAT THE PATIENTS' INDICATION FOR ECP TREATMENT WAS EITHER DUE TO ACUTE GVHD (81.5%) OR CHRONIC GVHD (18.5%). THE AUTHORS STATED THAT RUXOLITINIB WAS PREVIOUSLY USED IN 53.8% OF THE PATIENTS. THE AUTHORS REPORTED THAT A TOTAL OF 546 ECP PROCEDURES WERE PERFORMED AND EACH PATIENT UNDERWENT AN AVERAGE OF 17 PROCEDURES (RANGE 5-39). THE AUTHORS STATED THAT A CENTRAL VENOUS CATHETER WAS USED IN THE MAJORITY OF THE CASES (97.6%) AND A BLOOD PRIME WAS REQUIRED FOR TWELVE PATIENTS (44.5%). THE AUTHORS REPORTED THAT IN THIS STUDY THERE WAS ONLY ONE SERIOUS ADVERSE EVENT, AN AIR EMBOLISM, WHICH WAS SUCCESSFULLY TREATED IN THE EMERGENCY ROOM. THE AUTHORS STATED THAT THERE WERE ALSO SEVEN CASES OF CENTRAL LINE INFECTIONS WHICH WERE NOT CONSIDERED SERIOUS. THE AUTHORS REPORTED THAT NO OTHER ADVERSE EVENTS WERE REPORTED. THE AUTHORS STATED THAT IN TERMS OF EFFICACY, 88.9% OF THE PATIENTS ACHIEVED EITHER PARTIAL (11 PATIENTS, 40.8%) OR COMPLETE REMISSION (13 PATIENT, 48.1%) OF THEIR GVHD. THE AUTHORS STATED THAT ONE PATIENT EXPERIENCED DISEASE PROGRESSION, AND TWO PATIENTS WERE NOT EVALUATED. THE AUTHORS CONCLUDED BY STATING THAT IN THIS LARGE PEDIATRIC STUDY, THEIR RESULTS CONFIRMED THAT ECP TREATMENT IS A FEASIBLE OPTION EVEN IN YOUNGER PATIENTS, WITH A GOOD RESPONSE RATE AND AN ACCEPTABLE SAFETY PROFILE IN THE PEDIATRIC POPULATION. IN A FOLLOW-UP WITH THE AUTHOR, THE AUTHOR STATED THAT A PATIENT IN THIS RETROSPECTIVE STUDY EXPERIENCED RESPIRATORY FAILURE DURING AN ECP TREATMENT PROCEDURE, AND THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM WHERE THEY WERE DIAGNOSED WITH AN AIR EMBOLISM. THE AUTHOR STATED THAT THE PATIENT WAS SUCCESSFULLY TREATED FOR THEIR AIR EMBOLISM WHILE IN THE EMERGENCY ROOM. THE AUTHOR STATED THAT THEY WERE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION CONCERNING EITHER THIS EVENT OR FOR THE CENTRAL LINE INFECTIONS. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895576 CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM LNR MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R