BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 7387226 · Received March 30, 2018

    Report

    Report Number
    1722028-2018-00081
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    February 22, 2018
    Report Date
    March 30, 2018
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    K172590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER STATED THAT THE PATIENT UNDERWENT AN ECP TREATMENT WITH THE CELLEX DEVICE MANUFACTURED BY THERAKOS ON (B)(6) 2018 FOLLOWED BY TREATMENT WITH THE SPECTRA OPTIA COLLECTION PROCEDURE ON (B)(6) 2018. PER THE CUSTOMER, ALL OF THE PATIENT'S ECP TREATMENTS WERE PERFORMED USING A PERIPHERAL ACCESS. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: FURTHER EVALUATION OF THIS EVENT HAS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOR IS THERE A LIKELY POTENTIAL FOR DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT BASED ON ADDITIONAL INVESTIGATIONAL INFORMATION. PER CUSTOMER, THE PATIENT WAS UNDERGOING TREATMENT ON BOTH THE SPECTRA OPTIA AND THERAKOS CELLEX. THE CUSTOMER REPORTED THE COMPLAINT TO THERAKOS FOR THE CELLEX PRODUCT AND THE COMPLIANT WAS FORWARDED TO TERUMO BCT BY THERAKOS. DURING FOLLOW-UP WITH THE CUSTOMER SITE BY TERUMO BCT, IT WAS CONFIRMED THAT THE REPORTED INCIDENT THAT OCCURRED IS NOT RELATED OR CAUSED BY THE ECP TREATMENTS PERFORMED ON THE SPECTRA OPTIA SYSTEM. THE PHYSICIAN AT THE CUSTOMER SITE DOES NOT BELIEVE THERE IS AN INCREASED RISK WITH ECP TREATMENTS ON SPECTRA OPTIA, THEREFORE, THE CUSTOMER DID NOT REPORT IT TO TERUMO BCT. INVESTIGATION IS IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION AND CORRECTED INFORMATION. INVESTIGATION: PER CUSTOMER, THE PRODUCT WAS COLLECTED BY THE OPTIA AND THEN TREATED WITH CELLEX AND IRRADIATED. AFTER TREATMENT WITH THE CELLEX, THE PRODUCT WAS THEN TRANSFUSED TO THE PATIENT. SUBSEQUENTLY, THE PATIENT DEVELOPED THROMBOSIS AND WAS HOSPITALIZED. THE CUSTOMER STRESSED THAT THEY HAD NO COMPLAINT WITH THE SPECTRA OPTIA SYSTEM AND INSTEAD REPORTED THE INCIDENT TO THE RAKOS. THIS RECORD WAS INITIATED WHEN TERUMO BCT WAS NOTIFIED BY THE RAKOS ON (B)(4) 2018. THE CUSTOMER IS NOT ALLEGING A DEFICIENCY WITH THE DEVICE OR THE DISPOSABLE. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT, THEREFORE, A DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE SIGNALS IN THE RDF AND ASSOCIATED IMAGES FOR THIS CMNC PROCEDURE CONFIRMED THAT THERE WERE NO UNUSUAL ALARMS OR EVENTS THAT OCCURRED THAT MAY BE ASSOCIATED WITH CLOTTING OR THE PRESENCE OF AIR DURING THE RUN. A SCHEDULED PREVENTIVE MAINTENANCE (PM) WAS PERFORMED ON THE MACHINE AS PER MANUFACTURER'S INSTRUCTIONS. THERE WERE NO DEFICIENCIES OR ISSUES NOTED WITH THE DEVICE AT THE TIME (POST-INCIDENT), AND NO ISSUES HAD BEEN REPORTED REGARDING THIS DEVICE IN THE TIME BETWEEN THE INCIDENT DATE AND THE DATE OF THE PM. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. ROOT CAUSE: REVIEW OF THE DLOG AND ASSOCIATED IMAGES FOR THIS CONTINUOUS MONONUCLEAR CELL (CMNC) PROCEDURE CONFIRMED THAT THERE WERE NO UNUSUAL ALARMS OR EVENTS THAT OCCURRED THAT MAY BE ASSOCIATED WITH CLOTTING DURING THE RUN. A DEFINITIVE ROOT CAUSE FOR THE CLOT THAT WAS EXPERIENCED BY THE CUSTOMER, AND THE SUBSEQUENT THROMBOSIS EXPERIENCED BY THE PATIENT, COULD NOT BE DETERMINED. PER THE PHYSICIAN AND CUSTOMER'S STATEMENT AND PER RDF REVIEW, THE INCIDENT WAS UNRELATED TO THE PROCEDURE PERFORMED ON THE SPECTRA OPTIA DEVICE. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO:- PATIENT PHYSIOLOGY AND/OR DISEASE STATE-COMPLICATIONS WITH THE SUBSEQUENT THERAKOS PROCEDURE- AC MANAGEMENT OF THE PROCEDURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT UNDERWENT A SPECTRA OPTIA COLLECTION PROCEDURE FOR EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT ON (B)(6) 2018. ON THE FOLLOWING DAY ((B)(6) 2018), THE PATIENT EXPERIENCED SHORTNESS OF BREATH WHICH PROGRESSIVELY WORSENED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018. PER THE CUSTOMER, THE PATIENT WAS DIAGNOSED WITH A SEGMENTAL PULMONARY ARTERY EMBOLISM IN THE LEFT LOWER LOBE, SUB SEGMENTAL PULMONARY ARTERY EMBOLISMS BILATERALLY, AND AN OLDER 3-LEVEL THROMBOSIS IN THE PATIENT'S RIGHT LEG. PER PHYSICIAN¿S ORDER AT THE HOSPITAL, THE PATIENT WAS GIVEN ANTICOAGULATION (AC) AND OXYGEN(O2) THERAPY. ON (B)(6) 2018, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH ANTICOAGULATION AND LONG-TERM OXYGEN THERAPY DUE TO SEVERELY IMPAIRED LUNG FUNCTION. PER THE CUSTOMER, THE PATIENT IS REPORTED IN STABLE CONDITION. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. PATIENT'S GENDER AND WEIGHT INFORMATION WERE OBTAINED FROM THE RUN DATA FILE (RDF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227222 SPECTRA OPTIA SPECTRA OPTIA IDL SET GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R