BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX

    MDR report key: 8595820 · Received May 9, 2019

    Report

    Report Number
    8595820
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    April 25, 2019
    Report Date
    April 29, 2019
    Manufacturer
    MALLINCKRODT HOSPITAL PRODUCTS, INC. (THERAKOS INC.)
    Product Code
    LNR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ARRIVED IN APHERESIS AREA IN GOOD HEALTH TO RECEIVE EXTRACORPORAL PHOTOPHORESIS WITH THE THERAKOS CELLEX MACHINE. THE NURSE DREW BLOOD FOR LABS BUT DREW A LARGE CLOT FROM THE LUMEN. RIGHT AFTER, THE PATIENT BECAME VISIBLY DISTRESSED. SHE COMPLAINED OF SHORTNESS OF BREATH AND STARTED TO COUGH. SHE COMPLAINED OF CHEST HEAVINESS. A STAT EKG WAS DONE, OXYGEN WAS APPLIED AND A REGISTERED RESPIRATORY THERAPIST (RRT) WAS CALLED. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED). IN THE ED, VIA ULTRASOUND A LARGE INTRAJUGULAR THROMBUS WAS DIAGNOSED ON ULTRASOUND. VQ (VENTILATION-PERFUSION SCAN) HIGH PROBABILITY OF PULMONARY EMBOLISM (PE) AND ADMISSION REQUIRED. PATIENT REPORTED NECK DISCOMFORT DURING PHOTOPHERESIS AND WAS ASKED TO BE SEEN FOR LINE ASSESSMENT. PER PATIENT, SHE HAS BEEN EXPERIENCING DISCOMFORT ON HER RIGHT NECK WITH MOTION, EATING AND SWALLOWING. SYMPTOMS STARTED THREE DAYS AFTER THE 8TH TREATMENT. A LARGE CLOT WAS REMOVED FROM THE CENTRAL LINE PRIOR TO PROCEDURE. MANUFACTURER RESPONSE FOR EXTRACORPOREAL PHOTOPHERESIS MACHINE, CELLEX (PER SITE REPORTER). PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388029 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR MALLINCKRODT HOSPITAL PRODUCTS, INC. (THERAKOS INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA Hospitalization| R