BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 21001872 · Received December 23, 2024

    Report

    Report Number
    1722028-2024-00567
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    September 7, 2024
    Report Date
    December 23, 2024
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE CUSTOMER REPORTED EVENT THE EVENT VIA MEDWATCH FORM MW5162142. THE CUSTOMER CONTACT WAS NOT PROVIDED; THEREFORE, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. A DEVICE/DISPOSABLE LOT HISTORY SEARCH COULD NOT BE PERFORMED BECAUSE THE CUSTOMER CHOSE TO REMAIN ANONYMOUS. BASED ON A LITERATURE REVIEW HIGH-DOSE METHYLPREDNISOLONE TO PREVENT PLATELET DECLINE IN PREECLAMPSIA BY OLIVIER POURRAT, MD, PHD ET AL. 2016 OBSTETRICS AND GYNECOLOGY VOL. 128, NO. 1, JULY 2016, PRE-ECLAMPSIA IS CHARACTERIZED BY RECENT-ONSET ARTERIAL HYPERTENSION TOGETHER WITH PROTEINURIA. THROMBOCYTOPENIA IS FREQUENT IN PREECLAMPSIA BECAUSE LOW PLATELET COUNTS ARE FOUND IN HALF OF PREECLAMPSIA CASES AND IS ONE OF THE FEATURES OF HEMOLYSIS, ELEVATED LIVER ENZYMES, AND LOW PLATELET COUNT (HELLP) SYNDROME IN ADDITION TO HEMOLYSIS AND ELEVATION OF LIVER ENZYMES. IT HAS BEEN ARGUED FOR MORE THAN 20 YEARS THAT TREATMENT WITH GLUCOCORTICOIDS COULD HELP TO STABILIZE HELLP SYNDROME BEFORE DELIVERY AND ACCELERATE ITS RECOVERY IN THE POSTPARTUM PERIOD. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THIS COMPLAINT. CAUSE FOR THE SENSOR FAILURE DURING TUBING SET LOADING COULD NOT BE DETERMINED BUT MAY BE DUE TO: A FAILURE OF THE DEVICE A PHYSICAL OBSTRUCTION PREVENTING CORRECT LOADING FUNCTION BASED ON THE AVAILABLE INFORMATION, CAUSE FOR THE ADMINISTRATION OF MEDICATION FOLLOWING A DELAY IN TPE TREATMENT WAS DUE TO THE PATIENT'S UNDERLYING PREECLAMPSIA CONDITION.

    Description of Event or Problem · 0

    PER MEDWATCH 5162142, A PATIENT WAS ADMITTED TO THE CARDIAC UNIT FOR HELLP (HEMOLYSIS, ELEVATED LIVER ENZYMES, LOW PLATELET COUNT) SYNDROME. THERE WAS A PLAN FOR THERAPEUTIC PLASMA EXCHANGE 5 TIMES OVER 7 DAYS. WHEN LOADING THE PLASMAPHERESIS MACHINE FOR THE FIRST TREATMENT, THERE WAS A MALFUNCTION OF A SENSOR AND THE TUBING WOULD NOT LOAD. THE MANAGER AND THE ON CALL PHYSICIAN WERE NOTIFIED. THE BIOMED AND REP FOR OPTIA ASSISTED WITH TROUBLESHOOTING, BUT THE MACHINE CONTINUED TO MALFUNCTION. PER MEDICAL DECISION, URGENT TRANSFER ORDERS WERE PLACED FOR APHERESIS TREATMENT. PRIOR TO TRANSFER THE PATIENT WAS TREATED WITH 1000MG OF SOLUMEDROL AND 2L OF FRESH FROZEN PLASMA. PATIENT ID, WEIGHT, AND OUTCOME WERE NOT PROVIDED BY THE CUSTOMER. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED AS THE CUSTOMER MARKED "SERIOUS INJURY" ON THE MEDWATCH FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79969 SPECTRA OPTIA SPECTRA OPTIA APHERESIS SYSTEM LKN TERUMO BCT 61000

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention| O