BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA

    MDR report key: 2671683 · Received July 26, 2012

    Report

    Report Number
    1722028-2012-00526
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    June 29, 2012
    Report Date
    June 29, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    NYO
    PMA / PMN Number
    BK070066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: A REVIEW OF THE PRODUCT DISPOSITION FORM (PDF) SYSTEM FOR THIS CATALOG NUMBER WAS PERFORMED AND NO PRODUCTION DEFECT RECORDS WERE FOUND. THE CUSTOMER WANTED TO KNOW THE ORDER OF OPERATIONS OF PEOPLE WHO INTERACTED WITH THE VISTA (SOFTWARE FOR ASSIGNING DONORS) SYSTEM. THIS WAS PROVIDED TO THEM VIA AUDIT TRAIL UTILITY IN VISTA. ROOT CAUSE: OPERATOR ERROR. CORRECTIVE ACTION: THE CUSTOMER IS HANDLING THE DOCUMENTATION ISSUES WITH THE RUN RECORDS ON THEIR END.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THE OPERATOR HAD ASSIGNED A DONOR TO A TRIMA PROCEDURE BUT THE PERSON RUN ON THE PROCEDURE WAS NOT THAT DONOR. THE TOTAL BLOOD VOLUME (TBV) THAT WAS CALCULATED WAS THEREFORE INCORRECT (IN THE UNSAFE DIRECTION, SO THE DONOR WAS RUN ON A HIGHER TBV THAN ACTUAL) FOR THIS DONOR AND THERE IS POTENTIAL FOR OVERINFUSION OF ANTI-COAGULANT. THIS WAS A SINGLE PLATELET PROCEDURE, AND THE DONOR DID NOT HAVE A REACTION DURING THE PROCEDURE, NOR DID THEY PRESENT ANY ISSUES AFTERWARD. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT'S AGE OR WEIGHT. THIS REPORT IS BEING FILED DUE TO OPERATOR ERROR THAT HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A DEATH OR INJURY IF THIS SAME FAILURE WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA VISTA INFORMATION SYSTEM NYO TERUMO BCT 923000320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other