BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITT BIOMEDICAL SERIES IV

    MDR report key: 299391 · Received October 6, 2000

    Report

    Report Number
    1039368-2000-00001
    Event Type
    Injury
    Date Received
    October 6, 2000
    Date of Event
    September 9, 2000
    Report Date
    September 11, 2000
    Manufacturer
    WITT BIOMEDICAL CORP.
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CATHETERIZATION PROCEDURE, THE PT WENT INTO FIBRILLATION AND THE CATH LAB TEAM BEGAN DEFIBRILLATION PROCEDURE. WITT'S "NIBP" CUFF WAS DISCONNECTED FROM THE "NIBP" HOSE, AND THE HOSE WAS LEFT LYING UNDER THE PT'S DRAPE. A NURSE REACHED UNDER THE DRAPE TO ATTACH AN IV LINE AND MISTAKENLY ATTACHED THE IV LINE TO THE WITT "NIBP" HOSE. THE MISTAKE WAS NOT DISCOVERED FOR AN HOUR. THE WITT SERIES IV WOULD NOT REGISTER "NIBP" AFTER SEVERAL ATTEMPTS TO INITIALIZE THE "NIBP" FROM THE HOST CENTRAL PROCESSING UNIT. WHEN THE STAFF CHECKED THE SERIES IV FRONT END CENTRAL PROCESSING UNIT, THEY FOUND BLOOD IN IT AND THEY DISCONNECTED THE IV LINE FROM THE "NIBP" HOSE. THE CATH LAB MGR ESTIMATES THE PT LOST APPROX 150 - 250 ML OF BLOOD. THE PT SURVIVED. THE "NIBP" HOSE AND CUFF ASSEMBLY IS PURCHASED FROM AN OEM VENDOR. THE "NIBP" CUFF ATTACHES TO THE "NIBP" HOSE WITH A LUER LOCK CONNECTOR WHICH IS COMPATIBLE WITH THE IV LINE LUER LOCK CONNECTOR AND ENABLED THE CONNECTION TO BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WITT BIOMEDICAL SERIES IV PHYSIOMONITORING/INFORMATION SYSTEM DRT WITT BIOMEDICAL CORP. SERIES IV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R