BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 5989335 · Received September 29, 2016

    Report

    Report Number
    2523595-2016-00217
    Event Type
    Death
    Date Received
    September 29, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 1, 2016
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    UDI-DI
    10705030100009
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A KIT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW COULD NOT BE PERFORMED. THE UVADEX LOT NUMBER WAS NOT PROVIDED. HOWEVER, A REVIEW OF ALL UVADEX LOTS MANUFACTURED SINCE JANUARY 2013 WAS PERFORMED. NO TRENDS OR NONCONFORMANCES RELATED TO THE COMPLAINT WERE NOTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, DEATH. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. FROM A DEVICE PERSPECTIVE, THERE WAS NO KNOWN DEVICE MALFUNCTION. HOWEVER, SINCE THE PHYSICIAN WAS NOT ABLE TO RULE OUT THE ECP TREATMENT AS A POSSIBLE CONTRIBUTING FACTOR IN THE PATIENT'S DEATH DUE TO THE FACT THAT AN AUTOPSY WAS NOT PERFORMED; THIS CASE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. 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: DEATH. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT A PATIENT WHO HAD RECENTLY STARTED EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENTS, HAD DIED SUDDENLY AND UNEXPECTEDLY. THE CUSTOMER STATED THAT THE PATIENT'S DEATH DID NOT OCCUR DURING A TREATMENT, AND THAT THIS EVENT WAS NOT RELATED TO A SPECIFIC TREATMENT. THE PATIENT'S PHYSICIAN WAS CONTACTED FOR ADDITIONAL INFORMATION. THE PHYSICIAN REPORTED THAT THEY WERE INFORMED BY THE PATIENT'S SISTER; THAT THE PATIENT COLLAPSED WHILE SHOPPING. THE PHYSICIAN STATED THAT RESUSCITATION WAS ATTEMPTED, BUT WITHOUT SUCCESS. THE PHYSICIAN REPORTED THAT NO AUTOPSY WAS PERFORMED. THE PHYSICIAN STATED THAT THE PATIENT'S DEATH COULD BE DUE TO A CARDIAC CAUSE. THE PHYSICIAN REPORTED THAT SHE THINKS A RELATIONSHIP WITH ECP IS VERY UNLIKELY, BUT THE PATIENT WAS NOT FURTHER EXAMINED. AFTER THE CALL THE PHYSICIAN SENT INFORMATION REGARDING THE PATIENT'S MEDICAL HISTORY AND MEDICATIONS, AND ALSO STATED IN THAT EMAIL; "ON (B)(6) 2016, THE PATIENT UNDERWENT TWO STRAIGHTFORWARD PHOTOPHERESIS ECP TREATMENTS. ON (B)(6) 2016, THE PATIENT DIED UNEXPECTEDLY OUTSIDE OF THE HOSPITAL FOLLOWING A SUDDEN LOSS OF CONSCIOUSNESS FOR WHICH THERE WAS MUG INTERVENTION. A CARDIAC CAUSE IS SUSPECTED GIVEN HER KNOWN CARDIAC DISEASE. ANOTHER POSSIBILITY COULD BE AN ACUTE THROMBOTIC / EMBOLIC EVENT, SECONDARY TO THE EXISTING DIALYSIS CATHETER, HOWEVER GIVEN THE PATIENT'S COMBINED ANTICOAGULANT THERAPY THIS SEEMS LESS LIKELY." THE KIT WAS NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638083 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC REQUEST NOT PROVIDED-KIT 10705030100009

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death