BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 3909524 · Received June 17, 2014

    Report

    Report Number
    3002124545-2014-00015
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A REPORT OF USER ERROR. MULTIPLE F/U ATTEMPTS (VMS ON (B)(4). EMAIL'S TO THE (B)(4) AND MEDICAL PHYSICIST (B)(4)) TO THE HOSPITAL RESULTED IN NO ADD'L INFO ON THE PT OUTCOME BEING SHARED BY THE HOSP. THE ONLY INFO WE WERE ABLE TO GET FROM THE HOSP WAS IN THE FORM OF AN EMAIL WHICH STATED "LET'S JUST SAY THAT IT HAD NOTHING TO DO WITH THE SCHEDULED THERASPHERES PT, AND EVERYTHING TO DO WITH A FAILURE TO FOLLOW POLICIES IN NUCLEAR MEDICINE AND SPECIAL PROCEDURES. IT WAS VERY UNFORTUNATE FOR OUR PT, WHOSE TREATMENT WAS SET BACK ALMOST 2 MORE WEEKS, BUT SHE IS NOW SCHEDULED TO RECEIVE HER SECOND LOBE TREATMENT ON (B)(6)." THE MEDICAL ASSESSMENT OF THIS EVENT WAS THAT USER ERROR IS REPORTABLE AND IN THE ABSENCE OF INFO ON THE PT OUTCOME THIS EVENT MUST BE REPORTED. THE ADMINISTRATION OF THERASPHERE RADIOACTIVE MICROSPHERES TO A PT OTHER THAN THE INTENDED PT COULD POSSIBLY LEAD TO A SERIOUS INJURY.

    Description of Event or Problem · 1

    (B)(4) CUSTOMER SERVICE RECEIVED A CALL FROM A MEDICAL PHYSICIST AT (B)(6). THEY WANTED TO RE-ORDER A THERASPHERE DOSE FOR A PT. WHEN ASKED THE REASON THEY NEEDED THE DOSE REPLACED THEY RESPONDED THAT THE REASON THE 4 GBG DOSE WAS NO LONGER AVAILABLE WAS IT HAD BEEN GIVEN TO THE WRONG PT. IT HAD BEEN WAITING IN STORAGE TO BE USED LATER THAT DAY ON THE PROPER PT WHEN IT WAS GIVEN TO A DIFFERENT PT WHO WAS IN THERE FOR AN "ANGIO". THE MEDICAL PHYSICIST ORDERING THE DOSE SAID THAT THEY DIDN'T WANT TO COMPLAIN OFFICIALLY BECAUSE THEY DIDN'T WANT THEIR NAME ON ANY OF THE PAPERWORK AS THEY HAD NOTHING TO DO WITH THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355957 THERASPHERE YTTRIUM-90 MICROSPHERES NAW BIOCOMPATIBLES U.K. LIMITED 4990105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other