BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 7441830 · Received April 18, 2018

    Report

    Report Number
    2523595-2018-00064
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    July 6, 2016
    Report Date
    June 6, 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 THEIR EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENTS AFTER THEIR DEEP VEIN THROMBOSIS DIAGNOSIS ON (B)(6) 2016. THE CUSTOMER REPORTED THAT THE PATIENT'S LAST ECP TREATMENT WAS ON (B)(6) 2017. THE CUSTOMER STATED THAT THE PATIENT PASSED ON (B)(6) 2017 DUE TO INFECTION AND GRAFT VERSUS HOST DISEASE (GVHD). THE CUSTOMER REPORTED THAT THE PATIENT'S INFECTION AND DEATH WERE DUE TO THE IMMUNOSUPPRESSION REQUIRED TO TREAT THE PATIENT'S GVHD. THE CUSTOMER STATED THAT THE PATIENT'S DEATH WAS UNRELATED TO THEIR REPORTED DEEP VEIN THROMBOSIS AND ALSO UNRELATED TO THEIR ECP TREATMENTS. THERE WAS NO SPECIFIC CELLEX INSTRUMENT SERIAL NUMBER MENTIONED IN THE COMPLAINT, HOWEVER THERE ARE ONLY TWO CELLEX INSTRUMENTS AT THIS SITE, 40616 AND 40617. NEITHER OF THESE INSTRUMENTS HAD UNDERGONE SERVICE PRIOR TO THE PATIENT'S ADVERSE EVENT. NO SERVICE WAS REQUESTED BY THE CUSTOMER FOR THIS ADVERSE EVENT. FOLLOWING THE EVENT, INSTRUMENT 40616 UNDERWENT PREVENTIVE MAINTENANCE ON 01-MAR-2017 AND INSTRUMENT 40617 UNDERWENT UNRELATED SERVICE ON 18-JUL-2016. DURING THESE SERVICES THE SYSTEM CHECKOUT PROCEDURE WAS SUCCESSFULLY COMPLETED INDICATING THAT THE INSTRUMENTS HAD PASSED ALL TESTS, MET ALL SPECIFICATIONS, AND WERE OPERATIONAL. (B)(4). (B)(6), 06/06/2018.

    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. NO INFORMATION WAS AVAILABLE TO ASSESS IF THE ECP TREATMENT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. 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 (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 INSTRUMENT'S, (B)(4), LAST SERVICES WERE PERFORMED ON 27-FEB-2018 AND 28-FEB-2018, RESPECTIVELY. DURING 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 WAS ASYMPTOMATIC AND THEIR DVT WAS DIAGNOSED THROUGH A ROUTINE CT SCAN ON (B)(6) 2016. THE CUSTOMER REPORTED THAT THE PATIENT'S DVT WAS TREATED WITH TINZAPARIN. THE CUSTOMER STATED THAT THEY BELIEVED THAT THE PATIENT'S DVT WAS LIKELY A LINE ASSOCIATED THROMBOSIS. THE CUSTOMER REPORTED THAT THE PATIENT HAD UNDERGONE ONE CYCLE 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) 2016 AND ACDA WAS USED AS THE ANTICOAGULANT IN THAT TREATMENT AT A 12:1 RATIO. THE CUSTOMER REPORTED THAT THE PATIENT IS CURRENTLY DECEASED. THE PATIENT'S CAUSE OF DEATH, DATE OF DEATH, AND ITS RELATIONSHIP TO THE ADVERSE EVENT WERE REQUESTED BUT NOT PROVIDED AS OF THE DATE OF THIS REPORT. NO PRODUCT WAS SPECIFIED IN THE CASE. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283875 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS NOT APPLICABLE NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention