BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 90T

    MDR report key: 268987 · Received March 9, 2000

    Report

    Report Number
    2221819-2000-00080
    Event Type
    Injury
    Date Received
    March 9, 2000
    Date of Event
    February 19, 2000
    Report Date
    February 22, 2000
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, A BLOOD-BACK EVENT OCCURRED. THE PT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. THE CATHETER WAS SURGICALLY REMOVED AFTER THE SECOND UNIT BECAME CONTAMINATED (REF MEDWATCH REPORT #2221819-2000-00083).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 90T IABP DSP DATASCOPE CORP. SYSTEM 90T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention