BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 6978330 · Received October 25, 2017

    Report

    Report Number
    2523595-2017-00187
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    September 19, 2017
    Report Date
    October 25, 2017
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE MEDICAL INTERVENTION OF THE SALINE THAT WAS GIVEN TO THE PATIENT AND ALSO DUE TO THE PATIENT BEING PLACED IN THE TRENDELENBURG POSITION. SINCE THIS EVENT IS ASSOCIATED WITH THE TREATMENT, THIS MDR WILL BE AGAINST THE INSTRUMENT. FROM A DEVICE PERSPECTIVE, THERE WAS NO KNOWN DEVICE MALFUNCTION AND NO INSTRUMENT ISSUE WAS ALLEGED BY THE CUSTOMER. NO SERVICE WAS REQUESTED BY THE CUSTOMER FOR THIS ADVERSE EVENT. THE CUSTOMER FULLY ACKNOWLEDGED THAT THIS ADVERSE EVENT WAS DUE TO USE ERROR AND NOT RELATED TO ANY ISSUE WITH THE INSTRUMENT. THE INSTRUMENT'S SERIAL NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, HYPOTENSION AND NAUSEA. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE 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. ADVERSE EVENT TERMS: HYPOTENSION AND NAUSEA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT DURING A DOUBLE NEEDLE MODE TREATMENT, THE COLLECT AND RETURN FLOW RATES WERE MISTAKENLY ADJUSTED SO THAT THE COLLECT FLOW RATE WAS 5 ML/MIN FASTER THAN THE RETURN FLOW RATE. THE CUSTOMER STATED THAT THIS FLOW RATE ISSUE LED TO THE PATIENT DEVELOPING A LARGE NEGATIVE FLUID BALANCE AFTER 1000 ML OF WHOLE BLOOD PROCESSED. THE CUSTOMER REPORTED THAT THE PATIENT THEN BECAME HYPOTENSIVE. THE CUSTOMER STATED THAT SALINE WAS ADMINISTERED TO THE PATIENT AND THAT THE PATIENT WAS ALSO PLACED IN THE TRENDELENBURG POSITION. THE CUSTOMER REPORTED THAT THE TREATMENT WAS ENDED WITH BLOOD RETURNED TO THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT WAS SLIGHTLY NAUSEOUS FOR A SHORT WHILE BUT WAS FULLY STABLE WITHIN A COUPLE OF HOURS. THE CUSTOMER REPORTED THAT THEY FULLY ACKNOWLEDGED THAT THIS ADVERSE EVENT WAS DUE TO OPERATOR ERROR AND NOT RELATED TO ANY ISSUE WITH THE INSTRUMENT. THE CUSTOMER WAS REMINDED ON HOW TO USE THE INSTRUMENT'S FLUID BALANCE LIMIT SETTINGS IN ORDER TO AVOID A SIMILAR EVENT IN THE FUTURE. THE CUSTOMER STATED THAT THEY DID NOT DOCUMENT THE SERIAL NUMBER OF THE INSTRUMENT THAT WAS USED FOR THIS TREATMENT. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757318 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS, INC NOT APPLICABLE NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention