BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 9426837 · Received December 5, 2019

    Report

    Report Number
    MW5091508
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    September 10, 2019
    Report Date
    October 17, 2019
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN AUTOLOGOUS CELLULAR THERAPY (CTP) COLLECTION WAS PERFORMED ON A (B)(6) Y/O MALE, DIAGNOSED WITH MULTIPLE MYELOMA. THE CTP COLLECTION WAS PERFORMED PER PROTOCOL WITHOUT ANY ISSUES THROUGHOUT THE PROCEDURE, EXCEPT FOR A FEW OCCLUSION ALARMS TOWARDS THE LAST HOUR OF THE PROCEDURE WHICH WERE CENTRAL VENOUS CATHETER RELATED. THE PT PERIPHERAL CD 34 COUNT OF 90 AND A TOTAL OF 16.182 LITERS OF WHOLE BLOOD WAS PROCESSED VIA A TRIPLE LUMEN TRIFUSION CENTRAL VENOUS CATHETER. ACDA-A RATIO USED THROUGHOUT THE PROCEDURE WAS 12:1. AT THE END OF THE PROCEDURE THE CTP LABELING WAS VERIFIED FOR ACCURACY AND VISUAL INSPECTION OF THE CTP WAS PERFORMED AND AUTHENTICATED BY TWO RNS. NO VISUAL ABNORMALITIES OF THE CTP WERE NOTED PRIOR TO DISTRIBUTION TO THE PROCESSING FACILITY. THE PROCESSING FACILITY PERSONNEL WHO ACCEPTED THE CTP ALSO CONFIRMED THE VISUAL INSPECTION OF THE CTP SHOWED NO ABNORMALITIES AT THE TIME OF DISTRIBUTION. AT APPROX 1400, AS STATED BY THE PROCESSING FACILITY PERSONNEL, THE MD WAS NOTIFIED AND HE VISUALLY ASSESSED THE CTP. AFTER CLOSE INSPECTION OF THE CTP, THE CTP WAS DEEMED UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215387 SPECTRA OPTIA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA THERAPEUTIC LKN TERUMO BCT, INC. SPECTRA PTIA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention