BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOINFUSER

    MDR report key: 494128 · Received November 7, 2003

    Report

    Report Number
    494128
    Event Type
    Other
    Date Received
    November 7, 2003
    Date of Event
    July 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    HAEMONETICS
    Product Code
    CAC
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ORTHROPAT PROCESS LIGHT WAS BLINKING ON POSTOP MODE. IT WILL NOT PROCESS AUTOMATICALLY, AND NEEDED TO BE PRESSED MANUALLY TO PROCESS MACHINE CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOINFUSER REINFUSION SALVAGED RBC CAC HAEMONETICS 1050 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR