BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 7509380 · Received May 11, 2018

    Report

    Report Number
    2523595-2018-00083
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    April 10, 2017
    Report Date
    June 11, 2018
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IN A FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2018, THE CUSTOMER STATED THAT THE PATIENT CONTINUED WITH AND COMPLETED ALL OF THEIR EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENTS AFTER THEIR DEEP VEIN THROMBOSIS DIAGNOSIS ON (B)(6) 2017. THE CUSTOMER REPORTED THAT THE PATIENT COMPLETED THEIR FINAL ECP TREATMENT ON (B)(6) 2018. THERE WAS NO SPECIFIC CELLEX INSTRUMENT SERIAL NUMBER MENTIONED IN THE COMPLAINT, HOWEVER THERE ARE ONLY TWO CELLEX INSTRUMENTS AT THIS SITE, (B)(4). INSTRUMENT 40616 UNDERWENT PREVENTIVE MAINTENANCE ON (B)(6) 2017 PRIOR TO THE ADVERSE EVENT. NO SERVICE WAS REQUESTED BY THE CUSTOMER FOR THIS ADVERSE EVENT. FOLLOWING THE EVENT, INSTRUMENT 40616 UNDERWENT UNRELATED SERVICE ON (B)(6) 2017. DURING EACH OF THE SERVICES THE SYSTEM CHECKOUT PROCEDURE WAS SUCCESSFULLY COMPLETED INDICATING THAT THE INSTRUMENT HAD PASSED ALL TESTS, MET ALL SPECIFICATIONS, AND WAS OPERATIONAL EACH TIME. INSTRUMENT 40617 UNDERWENT PREVENTIVE MAINTENANCE ON (B)(6) 2017 PRIOR TO THE PATIENT'S ADVERSE EVENT. NO SERVICE WAS REQUESTED BY THE CUSTOMER FOR THIS ADVERSE EVENT. FOLLOWING THE EVENT, INSTRUMENT 40617 UNDERWENT UNRELATED SERVICE ON (B)(6) 2017. DURING EACH OF THE SERVICES THE SYSTEM CHECKOUT PROCEDURE WAS SUCCESSFULLY COMPLETED INDICATING THAT THE INSTRUMENT HAD PASSED ALL TESTS, MET ALL SPECIFICATIONS, AND WAS OPERATIONAL EACH TIME. (B)(4). (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE MEDICAL INTERVENTION OF THE TINZAPARIN 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 INSTRUMENT ISSUE WAS ALLEGED BY THE CUSTOMER. NO SERVICE WAS REQUESTED BY THE CUSTOMER FOR THIS ADVERSE EVENT. THERE WAS NO SPECIFIC CELLEX INSTRUMENT SERIAL NUMBER MENTIONED IN THE COMPLAINT; HOWEVER, THERE ARE ONLY TWO CELLEX INSTRUMENTS LOCATED AT THIS CUSTOMER'S SITE, INSTRUMENT SERIAL NUMBERS (B)(4). NO PRODUCT WAS RETURNED; THEREFORE, A DEVICE SERVICE HISTORY REVIEW WAS PERFORMED. CELLEX INSTRUMENTS, (B)(4), HAVE BEEN LOCATED AT THE CUSTOMER'S SITE SINCE 23-FEB-2016. AS PART OF THE REVIEW, IT WAS DETERMINED THAT PRIOR TO THE EVENT THE INSTRUMENTS, (B)(4), UNDERWENT SCHEDULED PREVENTIVE MAINTENANCE ON 01-MAR-2017. THE INSTRUMENTS' LAST SERVICE WAS PERFORMED ON 27-FEB-2018 AND 28-FEB-2018, RESPECTIVELY. DURING ALL OF THESE SERVICES, THE SYSTEM CHECKOUT PROCEDURE WAS SUCCESSFULLY COMPLETED INDICATING THAT THE INSTRUMENTS HAD PASSED ALL TESTS, MET ALL SPECIFICATIONS, AND WERE OPERATIONAL. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, THROMBOSIS. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. 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: THROMBOSIS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED A DEEP VEIN THROMBOSIS (DVT). THE CUSTOMER STATED THAT THE PATIENT'S DVT WAS DIAGNOSED THROUGH A DOPPLER ULTRASOUND STUDY ON (B)(6) 2017. THE CUSTOMER REPORTED THAT THE PATIENT'S DVT WAS TREATED WITH TINZAPARIN. THE CUSTOMER STATED THAT THE PATIENT HAD NO OTHER OBVIOUS RISK FACTORS. THE CUSTOMER REPORTED THAT THE PATIENT HAD UNDERGONE 10 CYCLES OF ECP TREATMENTS PRIOR TO THEIR DVT DIAGNOSIS. THE CUSTOMER STATED THAT THE PATIENT'S LAST ECP TREATMENT PRIOR TO THEIR DVT DIAGNOSIS WAS ON (B)(6) 2017 AND ACDA WAS USED AS THE ANTICOAGULANT IN THAT TREATMENT AT A 12:1 RATIO. THE CUSTOMER REPORTED THAT THE PATIENT WAS DOING WELL AND HAD COMPLETED ALL OF THEIR ECP TREATMENTS. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349580 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS NOT APPLICABLE NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention