BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

    MDR report key: 19662809 · Received July 2, 2024

    Report

    Report Number
    3013428851-2024-00059
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    May 22, 2024
    Report Date
    July 2, 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, CHEST PAIN, HYPOTENSION, BRADYCARDIA, AND OXYGEN DESATURATION WERE RELATED TO THE PATIENT'S ECP TREATMENT PROCEDURE. HOWEVER, THE ROOT CAUSE FOR THE PATIENT'S DYSPNEA, CHEST PAIN, HYPOTENSION, BRADYCARDIA, AND OXYGEN DESATURATION 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 A CT SCAN WERE PERFORMED, AND THEY WERE BOTH NEGATIVE FOR ANY PATHOLOGY. 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, CHEST PAIN, HYPOTENSION, BRADYCARDIA, AND OXYGEN DESATURATION. 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, CHEST PAIN, LOW OXYGEN SATURATION, BRADYCARDIA, AND LOW BLOOD PRESSURE/HYPOTENSION COMP-055036 S.K.(B)(6) 2024

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED DYSPNEA, CHEST PAIN, HYPOTENSION, BRADYCARDIA, AND OXYGEN DESATURATION DURING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT EXPERIENCED DYSPNEA AND CHEST PAIN WITHIN TEN MINUTES OF STARTING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT'S BLOOD PRESSURE, PULSE, AND PULSE OX HAD ALSO DROPPED. THE CUSTOMER STATED THAT THE PATIENT'S PRE ECP-TREATMENT BLOOD PRESSURE AND PULSE WERE 109/71 MMHG AND 99 BEATS PER MINUTE, RESPECTIVELY. HOWEVER, THE CUSTOMER REPORTED THAT AT THE TIME OF THE EVENT THE PATIENT'S BLOOD PRESSURE, PULSE, AND OXYGEN SATURATION HAD DROPPED TO 84/55 MMHG, 54 BEATS PER MINUTE, AND 84%, RESPECTIVELY. THE CUSTOMER STATED THAT THEY THEN ADMINISTERED SUPPLEMENTAL OXYGEN AND IV FLUIDS TO THE PATIENT. THE CUSTOMER REPORTED THAT THEY ENDED THE PATIENT'S ECP TREATMENT PROCEDURE WITH BLOOD RETURNED TO THE PATIENT AND THE PATIENT'S CONDITION IMPROVED. THE CUSTOMER STATED THAT THEY PERFORMED AN EKG AND A CT SCAN, AND BOTH WERE NEGATIVE FOR ANY PATHOLOGY. THE CUSTOMER REPORTED THAT THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THE CUSTOMER STATED THAT THE PATIENT WILL NO LONGER BE CONTINUING WITH THEIR ECP TREATMENTS. THE CUSTOMER REPORTED THAT THEY BELIEVED THAT THE PATIENT'S DYSPNEA, CHEST PAIN, HYPOTENSION, BRADYCARDIA, AND OXYGEN DESATURATION 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
    579450 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