BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA

    MDR report key: 2840598 · Received November 20, 2012

    Report

    Report Number
    1722028-2012-00879
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 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: IT WAS CONFIRMED WITH THE CLINIC THAT THE PROCEDURE WAS DISCONTINUED AT APPROXIMATELY 25MIN. WITH MINIMAL PRODUCT COLLECTED AND RINSEBACK WAS PERFORMED. THE DONOR HAD NO ADVERSE EXPERIENCES. THIS IS A SOFTWARE PRODUCT WHICH DOES NOT HAVE AN ASSOCIATED TECHNICAL FILE, SIMPLY A BATCH WORK ORDER WHICH WOULD DOCUMENT ANY PRODUCTION DEFECTS. NONE WERE FOUND. ROOT CAUSE: OPERATOR ERROR. CORRECTIVE ACTION: (B)(4). OPERATOR ERROR, NO EVALUATION NECESSARY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POTENTIAL ANTICOAGULANT (AC) OVERINFUSION DUE TO INCORRECTLY ENTERED DONOR INFORMATION. THE PROCEDURE WAS DISCONTINUED AT 25 MINUTES AND RINSEBACK WAS PERFORMED. THE DONOR DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE INCIDENT. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION (IN THE FORM OF OPERATOR ERROR) THAT HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A DEATH OR INJURY.

    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 61 YR Other